FDA 510(k) Application Details - K970367

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K970367
Device Name	System, Thermal Regulating
Applicant	AQUARIUS MEDICAL CORP. 7525 EAST CAMELBACK RD. SUITE 210 SCOTTSDALE, AZ 85251 US Other 510(k) Applications for this Company
Contact	W. JEFFREY CHANDLER Other 510(k) Applications for this Contact
Regulation Number	870.5900   More FDA Info for this Regulation Number
Classification Product Code	DWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/1997
Decision Date	12/17/1997
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