Panels › Anesthesiology › Product code QZW · Class 2
Over-The-Counter Device To Assess Risk Of Sleep Apnea
Regulation 868.2378
1510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QZW
| Company | 510(k)s | Recalls |
|---|---|---|
| Samsung Electronics Co., Ltd. | 2 | 0 |
| Apple, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 20, 2026 | K261011 | Sleep Apnea Feature (v2.0) Samsung Electronics Co., Ltd., KR | QZW |
| Sep 13, 2024 | K240929 | Sleep Apnea Notification Feature (SANF) Apple, Inc. | QZW |
| Feb 6, 2024 | DEN230041 | Sleep Apnea Feature Samsung Electronics Co., Ltd., KR | QZW |
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