FDA 510(k) Application Details - K991561

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K991561
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	DHD HEALTHCARE CORP. ONE MADISON ST. WAMPSVILLE, NY 13163 US Other 510(k) Applications for this Company
Contact	LARRY WEINSTEIN 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	05/04/1999
Decision Date	11/10/1999
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