FDA 510(k) Application Details - K965070

Device Classification Name	More FDA Info for this Device
510(K) Number	K965070
Device Name	SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.
Applicant	MECTA CORP. 7015 S.W. MC EWAN RD. LAKE OSWEGO, OR 97035 US Other 510(k) Applications for this Company
Contact	ROBIN H NICOL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QGH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/1996
Decision Date	03/06/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review