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FDA 510(k)

TD-7301 Peak Flow meter

K-Number: K222810 · 2023-12-19

ApplicantGostar Co., Ltd.
Decision Date2023-12-19
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TD-7301 Peak Flow meter is the device name listed in this FDA 510(k) record. The listed applicant is Gostar Co., Ltd.. It received FDA 510(k) clearance on 2023-12-19 under 510(k) number K222810. 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 TD-7301 Peak Flow meter?

TD-7301 Peak Flow meter is a medical device that received FDA 510(k) clearance on 2023-12-19. The listed applicant is Gostar Co., Ltd.. The 510(k) number is K222810.

When did TD-7301 Peak Flow meter receive FDA 510(k) clearance?

TD-7301 Peak Flow meter received FDA 510(k) clearance on 2023-12-19, under 510(k) number K222810.

Who is the listed applicant for TD-7301 Peak Flow meter?

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

What is the FDA product code for TD-7301 Peak Flow meter?

The FDA product code for TD-7301 Peak Flow meter is BZH.

Other records listing Gostar 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.

K241843TD-7301 Spirometer (TD-7301)K221419TD-5010 Lancing Device and TD-5084 Sterile Lancets

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.K203196Peak flow meterShanghai Sonmol Medical Equipment 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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