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FDA 510(k)

ASTHMA MONITOR AM2

K-Number: K980876 · 1998-08-14

ApplicantErich Jaeger GmbH & Co. KG
Decision Date1998-08-14
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ASTHMA MONITOR AM2 is the device name listed in this FDA 510(k) record. The listed applicant is Erich Jaeger GmbH & Co. KG. It received FDA 510(k) clearance on 1998-08-14 under 510(k) number K980876. 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 AM2?

ASTHMA MONITOR AM2 is a medical device that received FDA 510(k) clearance on 1998-08-14. The listed applicant is Erich Jaeger GmbH & Co. KG. The 510(k) number is K980876.

When did ASTHMA MONITOR AM2 receive FDA 510(k) clearance?

ASTHMA MONITOR AM2 received FDA 510(k) clearance on 1998-08-14, under 510(k) number K980876.

Who is the listed applicant for ASTHMA MONITOR AM2?

The FDA 510(k) record lists Erich Jaeger GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASTHMA MONITOR AM2?

The FDA product code for ASTHMA MONITOR AM2 is BZG.

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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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