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FDA 510(k)

MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER

K-Number: K961779 · 1997-06-13

ApplicantAvion Medical Products, Inc.
Decision Date1997-06-13
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER is the device name listed in this FDA 510(k) record. The listed applicant is Avion Medical Products, Inc.. It received FDA 510(k) clearance on 1997-06-13 under 510(k) number K961779. 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-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER?

MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER is a medical device that received FDA 510(k) clearance on 1997-06-13. The listed applicant is Avion Medical Products, Inc.. The 510(k) number is K961779.

When did MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER receive FDA 510(k) clearance?

MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER received FDA 510(k) clearance on 1997-06-13, under 510(k) number K961779.

Who is the listed applicant for MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER?

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

What is the FDA product code for MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER?

The FDA product code for MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER is BZH.

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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

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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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