OUW — Infant Positioner, Rx, Use In Highly Monitored Setting Class I
FDA product code OUW covers "Infant Positioner, Rx, Use In Highly Monitored Setting", a Class I medical device regulated under 21 CFR 880.5680. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OUW
- Device Class
- Class I
- Regulation Number
- 880.5680
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
Designed to position the baby at a 30 degree angle in the prone (on his/her stomach) position for specific medical or surgical conditions. For use only when in a highly monitored setting with continuous cardio-respiratory and oxygen saturation monitoring.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172962 | neonatal loving kare | Nurture Rest | January 18, 2018 |