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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 a medical device manufactured by Gostar Co., Ltd.. It received FDA 510(k) clearance on 2023-12-19 under approval 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. It is manufactured by Gostar Co., Ltd.. The 510(k) number is K222810.

When was TD-7301 Peak Flow meter approved by the FDA?

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

What company makes TD-7301 Peak Flow meter?

TD-7301 Peak Flow meter is manufactured by Gostar Co., Ltd..

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 Devices by Gostar Co., Ltd.

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

Related Devices (Code: BZH)

K152276Wing Smart FEVI and Peak Flow MeterSparo, Inc. K170281MSA100BT Peak Flow MeterBeijing M&B Electronic Instruments Co., Ltd. K180487Peak.meBreathe Me, Ltd. K181666Smart OneMir Medical International Research K172804Besmed Peak Flow MeterBesmed Health Business Corp K191239Smart Peak Flow MeterGuangzhou Homesun Medical Technology 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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