FDA 510(k) Application Details - K241338

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K241338
Device Name	Meter, Peak Flow, Spirometry
Applicant	Chongqing Moffy Innovation Technology Co.,Ltd. No.292 Jingdongfang Rd.Beibei Dist Chongqing 400714 CN Other 510(k) Applications for this Company
Contact	Yongxu Li 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	05/13/2024
Decision Date	12/31/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review