Panels › Cardiovascular › Product code OLK · Class 2
Pulse Oximeter For Over-The-Counter Use
Regulation 870.2700
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OLK
| Company | 510(k)s | Recalls |
|---|---|---|
| Masimo Corporation | 1 | 0 |
| Nonin Medical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 13, 2024 | K211498 | Nonin OTC Pulse Oximeter Model 3250 Nonin Medical, Inc. | OLK |
| Jan 31, 2024 | K214115 | MightySat -OTC Masimo Corporation | OLK |
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