OUW

Infant Positioner, Rx, Use In Highly Monitored Setting

Product code

OUW

Device name

Infant Positioner, Rx, Use In Highly Monitored Setting

Device class

Class 1

21 CFR

21 CFR 880.5680

Medical specialty

General Hospital

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).