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FDA 510(k)

AEROGEAR ASTHMA ACTION KIT

K-Number: K964130 · 1997-01-10

ApplicantMonaghan Medical Corp.
Decision Date1997-01-10
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROGEAR ASTHMA ACTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Monaghan Medical Corp.. It received FDA 510(k) clearance on 1997-01-10 under 510(k) number K964130. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEROGEAR ASTHMA ACTION KIT?

AEROGEAR ASTHMA ACTION KIT is a medical device that received FDA 510(k) clearance on 1997-01-10. The listed applicant is Monaghan Medical Corp.. The 510(k) number is K964130.

When did AEROGEAR ASTHMA ACTION KIT receive FDA 510(k) clearance?

AEROGEAR ASTHMA ACTION KIT received FDA 510(k) clearance on 1997-01-10, under 510(k) number K964130.

Who is the listed applicant for AEROGEAR ASTHMA ACTION KIT?

The FDA 510(k) record lists Monaghan Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AEROGEAR ASTHMA ACTION KIT?

The FDA product code for AEROGEAR ASTHMA ACTION KIT is BZH.

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Official Source

View on FDA Database →

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

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