MODIFICATION TO INFANT LIFE SUPPORT MODULE-20— 510(k) K022876

Name: FDA 510(k) clearance K022876
Creator: U.S. Food and Drug Administration
Published: 2002-09-11

Substantially Equivalent

International Biomedical, Inc.

FDA 510(k) clearance K022876 for MODIFICATION TO INFANT LIFE SUPPORT MODULE-20, Substantially Equivalent on 2002-09-11. Applicant: International Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: International Biomedical, Inc.
Product code: Code FPL
Device class: Class 2
Regulation: 21 CFR 880.5410
Advisory panel: General Hospital
Date received: 2002-08-30
Decision date: 2002-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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