FDA 510(k) Application Details - K963373

Device Classification Name	Calculator, Pulmonary Function Data   More FDA Info for this Device
510(K) Number	K963373
Device Name	Calculator, Pulmonary Function Data
Applicant	COSMED S.R.L. 1129 BLOOMFIELD AVE. WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	ANNE MARIE CESARIO Other 510(k) Applications for this Contact
Regulation Number	868.1880   More FDA Info for this Regulation Number
Classification Product Code	BZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/1996
Decision Date	09/10/1997
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