FDA 510(k) Application Details - K172804

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K172804
Device Name	Meter, Peak Flow, Spirometry
Applicant	Besmed Health Business Corp. No.5, Lane 116, Wu-Kong 2nd Rd Wu-Ku District TW Other 510(k) Applications for this Company
Contact	Lawrence Wu 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	09/18/2017
Decision Date	01/11/2018
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