FDA 510(k) Application Details - K972824

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K972824
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	PN MEDICAL 214 NORTH GOLDENROD RD., #6 ORLANDO, FL 32807 US Other 510(k) Applications for this Company
Contact	PEGGY NICHOLSON 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	07/30/1997
Decision Date	04/03/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review