FDA 510(k) Application Details - K012387

Device Classification Name	Calculator, Pulmonary Function Interpretator (Diagnostic)   More FDA Info for this Device
510(K) Number	K012387
Device Name	Calculator, Pulmonary Function Interpretator (Diagnostic)
Applicant	STETHOGRAPHICS, INC. 11874 S. EVELYN CIRCLE HOUSTON, TX 77071 US Other 510(k) Applications for this Company
Contact	HARVEY KNAUSS Other 510(k) Applications for this Contact
Regulation Number	868.1900   More FDA Info for this Regulation Number
Classification Product Code	BZM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2001
Decision Date	04/23/2002
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