FDA 510(k) Application Details - K974848

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K974848
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	HOUGEN MFG., INC. 3001 HOUGEN DR. SWARTZ CREEK, MI 48473 US Other 510(k) Applications for this Company
Contact	JEFFERY R MILLER 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	12/29/1997
Decision Date	08/06/1998
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