T-STAT 303 ISCHEMIA MONITORING SYSTEM


Device Classification Name

oximeter, tissue saturation

510(k) Number K081233
Device Name T-STAT 303 ISCHEMIA MONITORING SYSTEM
Applicant
SPECTROS CORPORATION
9433 south morning glory lane
highlands ranch, 
CO 
80130

Applicant Contact bill curnan
Correspondent
SPECTROS CORPORATION
9433 south morning glory lane
highlands ranch, 
CO 
80130

Correspodent Contact bill curnan
Regulation Number 870.2700
Classification Product Code
MUD  
Date Received 05/01/2008
Decision Date 07/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No