OUW
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Infant Positioner, Rx, Use In Highly Monitored Setting
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5680
- Medical specialty
- General Hospital
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Nurture Rest (K172962) | Neonatal Loving Kare, Inc. | 2018-01-18 | + Add |
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Every clearance here is in the API, with alerts when new ones post.