FDA 510(k) Application Details - K133873

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K133873
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	BESMED HEALTH BUSINESS CORP. NO.5, LANE116, WU-KONG 2ND RD NEW TAIPEI CITY, WU-KU DISTRICT TAIWAN TW Other 510(k) Applications for this Company
Contact	PAUL DRYDEN Other 510(k) Applications for this Contact
Regulation Number	868.5690   More FDA Info for this Regulation Number
Classification Product Code	BWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2013
Decision Date	04/04/2014
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