KOZY COMFORT INFANT POSITIONER— 510(k) K062143

Name: FDA 510(k) clearance K062143
Creator: U.S. Food and Drug Administration
Published: 2006-10-24

Substantially Equivalent

Alfred E Mann Inst. For Biomedical Engineering

FDA 510(k) clearance K062143 for KOZY COMFORT INFANT POSITIONER, Substantially Equivalent on 2006-10-24. Applicant: Alfred E Mann Inst. For Biomedical Engineering. Device class: 1.

Clearance details

Applicant: Alfred E Mann Inst. For Biomedical Engineering
Product code: Code FRP
Device class: Class 1
Regulation: 21 CFR 880.5680
Advisory panel: General Hospital
Date received: 2006-07-27
Decision date: 2006-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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