FDA 510(k) Application Details - K222810

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K222810
Device Name	Meter, Peak Flow, Spirometry
Applicant	GOSTAR Co., Ltd. 2F, No.65, Wuquan 7nd Rd. New Taipei City 248020 TW Other 510(k) Applications for this Company
Contact	Pei-Fen Yang Other 510(k) Applications for this Contact
Regulation Number	868.1860   More FDA Info for this Regulation Number
Classification Product Code	BZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2022
Decision Date	12/19/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review