FDA 510(k) Application Details - K963376

Device Classification Name	System, Breath Measurement   More FDA Info for this Device
510(K) Number	K963376
Device Name	System, Breath Measurement
Applicant	MICRO DIRECT, INC. P.O. BOX 239 840 POWNAL ROAD AUBURN, ME 04210-0239 US Other 510(k) Applications for this Company
Contact	DAVID STASZAK Other 510(k) Applications for this Contact
Regulation Number	862.1820   More FDA Info for this Regulation Number
Classification Product Code	NRH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/1996
Decision Date	01/24/1997
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