Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K222597
BabySat 3 · Owlet Babycare, Inc. · decided 2023-06-16 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| BabySat 3 Rx Sensor | OSS 3.0-M1 | Owlet Baby Care, Inc. | DQA | 00810099090031 |
| BabySat Monitoring System | OSS 3.0-M1; OBL 3.0-M1 | Owlet Baby Care, Inc. | DQA | 00810099090086 |
| BabySat 3 Rx App | 2.23.0 | Owlet Baby Care, Inc. | DQA | 00810099090079 |
| BabySat 3 Rx Base Station | OBL 3.0-M1 | Owlet Baby Care, Inc. | DQA | 00810099090024 |