FDA 510(k) Application Details - K203196

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K203196
Device Name	Meter, Peak Flow, Spirometry
Applicant	Shanghai Sonmol Medical Equipment Co., Ltd. Room 116-118, Building 21,No.500 Jiajian Road, Jiading District Shanghai CN Other 510(k) Applications for this Company
Contact	Li Yong Xu 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	10/28/2020
Decision Date	05/26/2021
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