510(k) K172962
K172962 is an FDA 510(k) premarket notification submitted by Neonatal Loving Kare, Inc. for the device "Nurture Rest". The FDA issued a decision of Substantially Equivalent on January 18, 2018. The device falls under product code OUW (Infant Positioner, Rx, Use In Highly Monitored Setting), a Class I device regulated under 21 CFR 880.5680.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2018
- Date Received
- September 26, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Infant Positioner, Rx, Use In Highly Monitored Setting
- Device Class
- Class I
- Regulation Number
- 880.5680
- Review Panel
- HO
- Submission Type
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.