FDA 510(k) Application Details - K003368

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K003368
Device Name	System, Thermal Regulating
Applicant	AQUARIUS MEDICAL CORP. 16047 NORTH 82ND ST. SUITE B-1 SCOTTSDALE, AZ 85260 US Other 510(k) Applications for this Company
Contact	CHRISTINA M FLEMING 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	10/30/2000
Decision Date	01/19/2001
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