FDA 510(k) Application Details - K000314

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K000314
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	ENGINEERED MEDICAL SYSTEMS 2055 EXECUTIVE DR. INDIANAPOLIS, IN 46241 US Other 510(k) Applications for this Company
Contact	BONNIE HOLLY 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	02/01/2000
Decision Date	04/12/2000
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