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FDA 510(k)

PEAK FLOW MONITOR

K-Number: K813414 · 1981-12-31

ApplicantBiotrine Corp.
Decision Date1981-12-31
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEAK FLOW MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Biotrine Corp.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813414. 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 PEAK FLOW MONITOR?

PEAK FLOW MONITOR is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Biotrine Corp.. The 510(k) number is K813414.

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

PEAK FLOW MONITOR received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813414.

Who is the listed applicant for PEAK FLOW MONITOR?

The FDA 510(k) record lists Biotrine Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEAK FLOW MONITOR?

The FDA product code for PEAK FLOW MONITOR 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.

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Other records listing Biotrine Corp. 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.

K915060ASTECH HOME PEAK FLOW METERK883704MULTIICHALLENGE NEBULIZER SYSTEMK863134MULTISPIRO SA/100K844226B-1000K812825FLO-COR I

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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