OUW · Class I · 21 CFR 880.5680

FDA Product Code OUW: Infant Positioner, Rx, Use In Highly Monitored Setting

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.

1
Total
1
Cleared
114d
Avg days
2018
Since

FDA 510(k) Cleared Infant Positioner, Rx, Use In Highly Monitored Setting Devices (Product Code OUW)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OUW - Regulatory Context