FDA 510(k) Application Details - K971570

Device Classification Name	Amplifier And Signal Conditioner, Biopotential   More FDA Info for this Device
510(K) Number	K971570
Device Name	Amplifier And Signal Conditioner, Biopotential
Applicant	QUINTON ELECTROPHYSIOLOGY CORP. 3303 MONTE VILLA PKWY. BOTHELL, WA 98021 US Other 510(k) Applications for this Company
Contact	MATTHEW HEDLUND 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	04/29/1997
Decision Date	12/29/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review