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FDA 510(k)

ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN

K-Number: K042058 · 2005-03-23

ApplicantClement Clarke Intl., Ltd.
Decision Date2005-03-23
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN 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 2005-03-23 under 510(k) number K042058. 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 ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN?

ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN is a medical device that received FDA 510(k) clearance on 2005-03-23. The listed applicant is Clement Clarke Intl., Ltd.. The 510(k) number is K042058.

When did ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN receive FDA 510(k) clearance?

ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN received FDA 510(k) clearance on 2005-03-23, under 510(k) number K042058.

Who is the listed applicant for ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN?

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 ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN?

The FDA product code for ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN is BZG.

Related Clinical Trials

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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.

K053156MINI-WRIGHT DIGITAL, MODEL 3120001K000368EYECAP IMAGING SYSTEMK982334AIRZONE PEAK FLOWMETERK980960IN-CHECK INSPIRATORY FLOWMETERK962074VM PLUS PEAK FLOWMETER

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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

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