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510(k) K222810

TD-7301 Peak Flow meter by Gostar Co., Ltd. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2023
Date Received
September 16, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Peak Flow, Spirometry
Device Class
Class II
Regulation Number
868.1860
Review Panel
AN
Submission Type

Other clearances by Gostar Co., Ltd.

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  • K221419 — TD-5010 Lancing Device and TD-5084 Sterile Lancets (January 20, 2023)

Other clearances for product code BZH

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  • K230423 — Electronic Peak Flow Meter (February 23, 2024)
  • K203196 — Peak flow meter (May 26, 2021)
  • K200832 — Safey Peak Flow Meter (July 30, 2020)
  • K193311 — Aluna (March 25, 2020)
  • K191239 — Smart Peak Flow Meter (December 6, 2019)
  • K180487 — Peak.me (October 26, 2018)
  • K181666 — Smart One (August 1, 2018)
  • K172804 — Besmed Peak Flow Meter (January 11, 2018)