AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX— 510(k) K103527

Name: FDA 510(k) clearance K103527
Creator: U.S. Food and Drug Administration
Published: 2011-04-15

Substantially Equivalent

International Biomedical, Ltd.

FDA 510(k) clearance K103527 for AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX, Substantially Equivalent on 2011-04-15. 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: 2011-04-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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