FDA 510(k) Application Details - K022660

Device Classification Name	Amplifier And Signal Conditioner, Biopotential   More FDA Info for this Device
510(K) Number	K022660
Device Name	Amplifier And Signal Conditioner, Biopotential
Applicant	BIOCHECK, INC. 9418 LASAINE AVE. NORTHRIDGE, CA 91325 US Other 510(k) Applications for this Company
Contact	ROBIN J HELLEN Other 510(k) Applications for this Contact
Regulation Number	870.2050   More FDA Info for this Regulation Number
Classification Product Code	DRR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2002
Decision Date	12/19/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review