A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX— 510(k) K103525

Name: FDA 510(k) clearance K103525
Creator: U.S. Food and Drug Administration
Published: 2011-05-11

Substantially Equivalent

International Biomedical, Ltd.

FDA 510(k) clearance K103525 for A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR 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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