FDA 510(k) Application Details - K170281

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K170281
Device Name	Meter, Peak Flow, Spirometry
Applicant	Beijing M&B Electronic Instruments Co., Ltd. No. 27, Yongwang Road, Daxing Bioengineering and Medicine Industry Base Beijing 101102 CN Other 510(k) Applications for this Company
Contact	Yang Shisheng 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	01/30/2017
Decision Date	10/06/2017
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