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FDA 510(k)

ASTHMA MONITOR MODEL, AM1

K-Number: K090486 · 2009-05-06

ApplicantCardinal Health Germany 234 GmbH
Decision Date2009-05-06
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ASTHMA MONITOR MODEL, AM1 is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health Germany 234 GmbH. It received FDA 510(k) clearance on 2009-05-06 under 510(k) number K090486. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASTHMA MONITOR MODEL, AM1?

ASTHMA MONITOR MODEL, AM1 is a medical device that received FDA 510(k) clearance on 2009-05-06. The listed applicant is Cardinal Health Germany 234 GmbH. The 510(k) number is K090486.

When did ASTHMA MONITOR MODEL, AM1 receive FDA 510(k) clearance?

ASTHMA MONITOR MODEL, AM1 received FDA 510(k) clearance on 2009-05-06, under 510(k) number K090486.

Who is the listed applicant for ASTHMA MONITOR MODEL, AM1?

The FDA 510(k) record lists Cardinal Health Germany 234 GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASTHMA MONITOR MODEL, AM1?

The FDA product code for ASTHMA MONITOR MODEL, AM1 is BZG.

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Other records listing Cardinal Health Germany 234 GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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