FDA 510(k) Application Details - K974322

Device Classification Name	Mass Spectrometer, Clinical Use   More FDA Info for this Device
510(K) Number	K974322
Device Name	Mass Spectrometer, Clinical Use
Applicant	EUROPA SCIENTIFIC, LTD. 325 COLLEGE RD. CONCORD, MA 01742 US Other 510(k) Applications for this Company
Contact	ROBERT F MARTIN Other 510(k) Applications for this Contact
Regulation Number	862.2860   More FDA Info for this Regulation Number
Classification Product Code	DOP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/1997
Decision Date	12/16/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review