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FDA 510(k)

AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER

K-Number: K012939 · 2001-09-28

ApplicantMonaghan Medical Corp.
Decision Date2001-09-28
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER 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 2001-09-28 under 510(k) number K012939. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER?

AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER is a medical device that received FDA 510(k) clearance on 2001-09-28. The listed applicant is Monaghan Medical Corp.. The 510(k) number is K012939.

When did AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER receive FDA 510(k) clearance?

AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER received FDA 510(k) clearance on 2001-09-28, under 510(k) number K012939.

Who is the listed applicant for AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER?

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 AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER?

The FDA product code for AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER is CAF.

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Other records listing Monaghan Medical Corp. 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

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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