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FDA 510(k)

MICROPEAK

K-Number: K030586 · 2003-08-27

ApplicantMicro Direct, Inc.
Decision Date2003-08-27
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MICROPEAK is the device name listed in this FDA 510(k) record. The listed applicant is Micro Direct, Inc.. It received FDA 510(k) clearance on 2003-08-27 under 510(k) number K030586. 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 MICROPEAK?

MICROPEAK is a medical device that received FDA 510(k) clearance on 2003-08-27. The listed applicant is Micro Direct, Inc.. The 510(k) number is K030586.

When did MICROPEAK receive FDA 510(k) clearance?

MICROPEAK received FDA 510(k) clearance on 2003-08-27, under 510(k) number K030586.

Who is the listed applicant for MICROPEAK?

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

What is the FDA product code for MICROPEAK?

The FDA product code for MICROPEAK is BZH.

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Other records listing Micro Direct, Inc. 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.

K033688MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITYK031102MICROLAB SPIROMETERK973314SPIROSAFE FILTERK965042MICRODL DIARYCARD SPIROMETERK963376MICRO H2K963035MICRO SPIROMETER

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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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