Infant Positioner, Rx, Use In Highly Monitored Setting

OUW · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.5680

Classification

FDA Product Code: OUW
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 880.5680
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown