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FDA 510(k)

MINI-WRIGHT DIGITAL, MODEL 3120001

K-Number: K053156 · 2006-01-31

ApplicantClement Clarke Intl., Ltd.
Decision Date2006-01-31
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MINI-WRIGHT DIGITAL, MODEL 3120001 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 2006-01-31 under 510(k) number K053156. 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 MINI-WRIGHT DIGITAL, MODEL 3120001?

MINI-WRIGHT DIGITAL, MODEL 3120001 is a medical device that received FDA 510(k) clearance on 2006-01-31. The listed applicant is Clement Clarke Intl., Ltd.. The 510(k) number is K053156.

When did MINI-WRIGHT DIGITAL, MODEL 3120001 receive FDA 510(k) clearance?

MINI-WRIGHT DIGITAL, MODEL 3120001 received FDA 510(k) clearance on 2006-01-31, under 510(k) number K053156.

Who is the listed applicant for MINI-WRIGHT DIGITAL, MODEL 3120001?

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 MINI-WRIGHT DIGITAL, MODEL 3120001?

The FDA product code for MINI-WRIGHT DIGITAL, MODEL 3120001 is BZH.

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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.

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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.

K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife CorporationK252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd.K241338Peak Flow MeterChongqing Moffy Innovation Technology Co., Ltd.K232588Aluna 2Knox Medical DiagnosticsK230423Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd.K222810TD-7301 Peak Flow meterGostar Co., Ltd.

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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