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FDA 510(k)

Smart Peak Flow Meter

K-Number: K191239 · 2019-12-06

ApplicantGuangzhou Homesun Medical Technology Co., Ltd.
Decision Date2019-12-06
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Smart Peak Flow Meter is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Homesun Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-06 under 510(k) number K191239. 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 Smart Peak Flow Meter?

Smart Peak Flow Meter is a medical device that received FDA 510(k) clearance on 2019-12-06. The listed applicant is Guangzhou Homesun Medical Technology Co., Ltd.. The 510(k) number is K191239.

When did Smart Peak Flow Meter receive FDA 510(k) clearance?

Smart Peak Flow Meter received FDA 510(k) clearance on 2019-12-06, under 510(k) number K191239.

Who is the listed applicant for Smart Peak Flow Meter?

The FDA 510(k) record lists Guangzhou Homesun Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart Peak Flow Meter?

The FDA product code for Smart Peak Flow Meter is BZH.

Other records listing Guangzhou Homesun Medical Technology Co., 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.

K231561Pulmonary Function Tester, Model: A9

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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