Beijing Choice Electronic Technololgy Co., Ltd.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Beijing Choice Electronic Technololgy Co., Ltd.” (first 2007, latest 2016), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 133 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 274 |
| 2013 | 4 | 183 |
| 2014 | 2 | 112 |
| 2015 | 3 | 141 |
| 2016 | 1 | 271 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 21 | 21 |
| DPS | Electrocardiograph | 3 | 3 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| KNG | Monitor, Ultrasonic, Fetal | 1 | 1 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 1 | 1 |
Review panels
- Anesthesiology (21)
- Cardiovascular (6)
- Neurology (1)
- Obstetrics and Gynecology (1)
Most recent Beijing Choice Electronic Technololgy Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160508 | Electronic Pulse Stimulator | NUH | 2016-11-21 | 271 |
| K151206 | Fingertip Pulse Oximeter | DQA | 2015-08-28 | 114 |
| K142888 | Fingertip Pulse Oximeter | DQA | 2015-02-20 | 141 |
| K141024 | EXTERNAL PULSE OXIMETER | DQA | 2015-01-13 | 267 |
| K141128 | FINGERTIP PULSE OXIMETER | DQA | 2014-08-13 | 104 |
| K140682 | FINGERTIP PULSE OXIMETER | DQA | 2014-07-17 | 121 |
| K131047 | FINGERTIP PULSE OXIMETER | DQA | 2013-10-16 | 184 |
| K130947 | FINGERTIP PULSE OXIMETER | DQA | 2013-10-03 | 182 |
| K123871 | FINGERTIP PULSE OXIMETER | DQA | 2013-05-10 | 144 |
| K122046 | WRIST PULSE OXIMETER | DQA | 2013-02-04 | 207 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Beijing Choice Electronic Technololgy Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Beijing Choice Electronic Technology Co., Ltd. (14 510(k)s)
- Beijing Adss Development Co., Ltd. (10 510(k)s)
- Beijing Biosis Healing Biolog Ical Technology Co., Ltd. (7 510(k)s)
- Beijing East Whale Imaging Technology Co., Ltd. (6 510(k)s)
- Beijing Nubway S&T Co., Ltd. (6 510(k)s)
- Beijing Sano Laser S&T Development Co.,Ltd (6 510(k)s)
- Beijing Zksk Technology Co., Ltd. (6 510(k)s)
- Beijing Honkon Technologies Co., Ltd. (5 510(k)s)
- Beijing Superlaser Technology Co., Ltd. (5 510(k)s)
- Beijing Demax Medical Technology Co.,Ltd (4 510(k)s)
- Beijing Fule Science & Technology Development Co., Ltd. (4 510(k)s)
- Beijing Globalipl Development Co., Ltd. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Beijing Choice Electronic Technololgy Co., Ltd.?
FDA lists 29 510(k) clearances under the applicant name “Beijing Choice Electronic Technololgy Co., Ltd.” (first 2007, latest 2016), across 6 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Beijing Choice Electronic Technololgy Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Beijing Choice Electronic Technololgy Co., Ltd. is 133 days.
Which FDA product codes appear under Beijing Choice Electronic Technololgy Co., Ltd.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 21); DPS (Electrocardiograph, 3); MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 2).
Next steps
- See all 29 Beijing Choice Electronic Technololgy Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Beijing Choice Electronic Technololgy Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.