K222597 is an FDA 510(k) clearance for the BabySat 3. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Owlet Babycare, Inc. (Lehi, US). The FDA issued a Cleared decision on June 16, 2023, 291 days after receiving the submission on August 29, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K222597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2022 |
| Decision Date | June 16, 2023 |
| Days to Decision | 291 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |