FDA 510(k) Application Details - K954492

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K954492
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	MERCURY MEDICAL 11300-A 49TH ST. NORTH CLEARWATER, FL 34622-4800 US Other 510(k) Applications for this Company
Contact	KATHY L HANN 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	09/27/1995
Decision Date	10/21/1996
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