Norav Medical , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Norav Medical , Ltd.” (first 2000, latest 2016), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 214 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 59 |
| 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 |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 3 | 3 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | 2 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Norav Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161062 | NR Recorder | MWJ | 2016-06-13 | 59 |
| K111487 | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE | MLO | 2011-11-10 | 163 |
| K110463 | PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) | MWI | 2011-11-10 | 266 |
| K080141 | PC ECG 1200W SYSTEM | MWI | 2008-04-25 | 94 |
| K012712 | NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 | MLO | 2002-05-08 | 267 |
| K000404 | PC ECG 1200 | MWI | 2000-11-22 | 289 |
Recalls
openFDA lists no recalls under a recalling firm named Norav Medical , 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 Norav Medical , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Norav Medical , Ltd.” (first 2000, latest 2016), across 3 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 Norav Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Norav Medical , Ltd. is 214 days.
Which FDA product codes appear under Norav Medical , Ltd.?
The most frequent FDA product codes under this applicant name are MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 3); MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm, 2); MWJ (Electrocardiograph, Ambulatory (Without Analysis), 1).
Next steps
- See all 6 Norav Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MWI, Norav Medical , 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.