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FDA 510(k)

DYNAMIPEAK PEAK FLOW METER

K-Number: K082899 · 2009-03-10

Decision Date2009-03-10
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DYNAMIPEAK PEAK FLOW METER is the device name listed in this FDA 510(k) record. The listed applicant is Dynamitech Medical, Inc.. It received FDA 510(k) clearance on 2009-03-10 under 510(k) number K082899. 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 DYNAMIPEAK PEAK FLOW METER?

DYNAMIPEAK PEAK FLOW METER is a medical device that received FDA 510(k) clearance on 2009-03-10. The listed applicant is Dynamitech Medical, Inc.. The 510(k) number is K082899.

When did DYNAMIPEAK PEAK FLOW METER receive FDA 510(k) clearance?

DYNAMIPEAK PEAK FLOW METER received FDA 510(k) clearance on 2009-03-10, under 510(k) number K082899.

Who is the listed applicant for DYNAMIPEAK PEAK FLOW METER?

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

What is the FDA product code for DYNAMIPEAK PEAK FLOW METER?

The FDA product code for DYNAMIPEAK PEAK FLOW METER is BZH.

Related Clinical Trials

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.

Related Devices (Code: BZH)

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.

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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