510(k) DEN220091
DEN220091 is an FDA 510(k) premarket notification submitted by Owlet Babycare, Inc. for the device "Dream Sock". The FDA issued a decision of De Novo Granted on November 8, 2023. The device falls under product code QYU (Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use), a Class II device regulated under 21 CFR 870.2705. Owlet Babycare, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 8, 2023
- Date Received
- December 14, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
- Device Class
- Class II
- Regulation Number
- 870.2705
- Review Panel
- CV
- Submission Type
An infant pulse rate and oxygen saturation monitor for over-the-counter use is a device that uses photoplethysmography to measure pulse rate and oxygen saturation in infants. The device may contain alarms that alert the caregiver when vital sign(s) go outside preset threshold(s).