ALLON 2001 VERSION 5


Device Classification Name

system, thermal regulating

510(k) Number K024128
Device Name ALLON 2001 VERSION 5
Original Applicant
MTRE ADVANCED TECHNOLOGY LTD.
6052 wilmington pike #225
centerville, 
OH 
45459

Original Contact douglas rash
Regulation Number 870.5900
Classification Product Code
DWJ  
Date Received 12/16/2002
Decision Date 02/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No