Panels › Cardiovascular › Product code QYU · Class 2
Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
Regulation 870.2705
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 QYU
| Company | 510(k)s | Recalls |
|---|---|---|
| Masimo Corporation | 1 | 0 |
| Owlet Babycare, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 3, 2024 | K234021 | Masimo Stork Masimo Corporation | QYU |
| Nov 8, 2023 | DEN220091 | Dream Sock Owlet Babycare, Inc. | QYU |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.