185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX— 510(k) K103523

Name: FDA 510(k) clearance K103523
Creator: U.S. Food and Drug Administration
Published: 2011-05-11

Substantially Equivalent

International Biomedical, Ltd.

FDA 510(k) clearance K103523 for 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX, Substantially Equivalent on 2011-05-11. Applicant: International Biomedical, Ltd.. Device class: 2.

Clearance details

Applicant: International Biomedical, Ltd.
Product code: Code FPL
Device class: Class 2
Regulation: 21 CFR 880.5410
Advisory panel: General Hospital
Date received: 2010-12-01
Decision date: 2011-05-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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