FDA 510(k) Application Details - K141355

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K141355
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	BESMED HEALTH BUSINESS CORPORATION No. 5, Lane 116, Wu-Kong 2nd Rd. Wu-ku District New Taipei City 24888 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	05/23/2014
Decision Date	09/03/2014
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