510(k) K222597
K222597 is an FDA 510(k) premarket notification submitted by Owlet Babycare, Inc. for the device "BabySat 3". The FDA issued a decision of Substantially Equivalent on June 16, 2023. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Owlet Babycare, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 2023
- Date Received
- August 29, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type