FDA 510(k) Application Details - K230423

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K230423
Device Name	Meter, Peak Flow, Spirometry
Applicant	Taian Dalu Medical Instrument Co., Ltd. West Part of Yitianmen Street, Hi-tech Zone Taian 271000 CN Other 510(k) Applications for this Company
Contact	Wang Yuqin 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	02/17/2023
Decision Date	02/23/2024
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