FDA.report

510(k) K222810

Device
TD-7301 Peak Flow meter
Applicant
Gostar Co., Ltd.
510(k) number
K222810
Product code
BZH
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-19
Date received
2022-09-16
Regulation
868.1860
Classification name
Meter, Peak Flow, Spirometry
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Pei-Fen Yang
Address
2f, #65, Wuquan 7nd Rd. Wugu District New Taipei City TW 248020 248020

FDA Registration Numbers

Source Documents

510(k) summary PDF

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