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FDA 510(k)

AIRZONE PEAK FLOWMETER

K-Number: K982334 · 1999-01-14

Decision Date1999-01-14
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRZONE PEAK FLOWMETER is the device name listed in this FDA 510(k) record. The listed applicant is Clement Clarke Intl., Ltd.. It received FDA 510(k) clearance on 1999-01-14 under 510(k) number K982334. 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 AIRZONE PEAK FLOWMETER?

AIRZONE PEAK FLOWMETER is a medical device that received FDA 510(k) clearance on 1999-01-14. The listed applicant is Clement Clarke Intl., Ltd.. The 510(k) number is K982334.

When did AIRZONE PEAK FLOWMETER receive FDA 510(k) clearance?

AIRZONE PEAK FLOWMETER received FDA 510(k) clearance on 1999-01-14, under 510(k) number K982334.

Who is the listed applicant for AIRZONE PEAK FLOWMETER?

The FDA 510(k) record lists Clement Clarke Intl., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIRZONE PEAK FLOWMETER?

The FDA product code for AIRZONE PEAK FLOWMETER 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.

Other records listing Clement Clarke Intl., Ltd. 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.

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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