ASTHMA MONITOR MODEL, AM1— 510(k) K090486

Name: FDA 510(k) clearance K090486
Creator: U.S. Food and Drug Administration
Published: 2009-05-06

Substantially Equivalent

Cardinal Health Germany 234 GmbH

FDA 510(k) clearance K090486 for ASTHMA MONITOR MODEL, AM1, Substantially Equivalent on 2009-05-06. Applicant: Cardinal Health Germany 234 GmbH. Device class: 2.

Clearance details

Applicant: Cardinal Health Germany 234 GmbH
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2009-02-25
Decision date: 2009-05-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Palm Springs, CA, US

Download summary PDF View on FDA.gov ↗

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