FDA 510(k) Application Details - K963005

Device Classification Name	Ph Rate Measurement, Carbon-Dioxide   More FDA Info for this Device
510(K) Number	K963005
Device Name	Ph Rate Measurement, Carbon-Dioxide
Applicant	NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454-9141 US Other 510(k) Applications for this Company
Contact	PAUL W MAC DONALD Other 510(k) Applications for this Contact
Regulation Number	862.1160   More FDA Info for this Regulation Number
Classification Product Code	JFL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/1996
Decision Date	08/23/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review