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FDA 510(k)

CLEAN PEAK FLOW METER

K-Number: K091412 · 2009-08-21

ApplicantViasys Healthcare GmbH
Decision Date2009-08-21
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CLEAN PEAK FLOW METER is the device name listed in this FDA 510(k) record. The listed applicant is Viasys Healthcare GmbH. It received FDA 510(k) clearance on 2009-08-21 under 510(k) number K091412. 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 CLEAN PEAK FLOW METER?

CLEAN PEAK FLOW METER is a medical device that received FDA 510(k) clearance on 2009-08-21. The listed applicant is Viasys Healthcare GmbH. The 510(k) number is K091412.

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

CLEAN PEAK FLOW METER received FDA 510(k) clearance on 2009-08-21, under 510(k) number K091412.

Who is the listed applicant for CLEAN PEAK FLOW METER?

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

What is the FDA product code for CLEAN PEAK FLOW METER?

The FDA product code for CLEAN PEAK FLOW METER is BZH.

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Other records listing Viasys Healthcare GmbH 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.

K092324SPIROPROK091505COR12+K081823MASTERSCREEN PAED - BABY BODYK080510VIP PULMONARY FUNCTION SYSTEMK080734FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CTK072061MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY

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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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