INFANT LIFE SUPPORT MODULE-20— 510(k) K854065

Name: FDA 510(k) clearance K854065
Creator: U.S. Food and Drug Administration
Published: 1986-01-16

Substantially Equivalent

Intl. Biomedics, Inc.

FDA 510(k) clearance K854065 for INFANT LIFE SUPPORT MODULE-20, Substantially Equivalent on 1986-01-16. Applicant: Intl. Biomedics, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Biomedics, Inc.
Product code: Code FPL
Device class: Class 2
Regulation: 21 CFR 880.5410
Advisory panel: General Hospital
Date received: 1985-10-04
Decision date: 1986-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleburne, TX, US

Download summary PDF View on FDA.gov ↗

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