RAPID THERMAL EXCHANGE SYSTEM


Device Classification Name

system, thermal regulating

510(k) Number K023934
Device Name RAPID THERMAL EXCHANGE SYSTEM
Original Applicant
AVACORE TECHNOLOGIES, INC.
251 high street, suite b
palo alto, 
CA 
94301

Original Contact craig coombs
Regulation Number 870.5900
Classification Product Code
DWJ  
Date Received 11/26/2002
Decision Date 01/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No