Shl Telemedicine International , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Shl Telemedicine International , Ltd.” (first 1998, latest 2012), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 | 1 | 86 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 3 | 3 |
| DPS | Electrocardiograph | 2 | 2 |
Review panels
- Cardiovascular (5)
Most recent Shl Telemedicine International , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113514 | SMARTHEART | DXH | 2012-02-22 | 86 |
| K080047 | CARDIOSEN'C | DXH | 2008-07-11 | 185 |
| K063609 | RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER | DXH | 2007-09-12 | 282 |
| K003392 | CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 | DPS | 2001-01-25 | 86 |
| K981807 | CARDIOVISION SOFTWARE, MODEL S-CV5-96 | DPS | 1998-08-19 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Shl Telemedicine International , 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Shl Telemedicine International , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Shl Telemedicine International , Ltd.” (first 1998, latest 2012), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shl Telemedicine International , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shl Telemedicine International , Ltd. is 90 days.
Which FDA product codes appear under Shl Telemedicine International , Ltd.?
The most frequent FDA product codes under this applicant name are DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 3); DPS (Electrocardiograph, 2).
Next steps
- See all 5 Shl Telemedicine International , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXH, Shl Telemedicine International , 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.