SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08


Device Classification Name

recorder,event,implantable cardiac,(without arrhythmia detection)

510(k) Number K073147
Device Name SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
Applicant
TRANSOMA MEDICAL
4358 west round lake rd.
arden hills, 
MN 
55112

Applicant Contact lisa stone
Correspondent
TRANSOMA MEDICAL
4358 west round lake rd.
arden hills, 
MN 
55112

Correspodent Contact lisa stone
Regulation Number 870.2800
Classification Product Code
MXC  
Date Received 11/08/2007
Decision Date 12/03/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No