FDA 510(k) Application Details - K991684

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K991684
Device Name	System, Thermal Regulating
Applicant	THERMOGEAR, INC. 18005 LOWER BOONES FERRY RD. TIGARD, OR 97224 US Other 510(k) Applications for this Company
Contact	R. WAYNE FIELDS 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	05/17/1999
Decision Date	03/01/2000
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