REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528


Device Classification Name

detector and alarm, arrhythmia

510(k) Number K103764
Device Name REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
Applicant
MEDTRONIC INC.
8200 coral sea st ne
mounds view, 
MN 
55112

Applicant Contact yukiko corson
Correspondent
MEDTRONIC INC.
8200 coral sea st ne
mounds view, 
MN 
55112

Correspodent Contact yukiko corson
Regulation Number 870.1025
Classification Product Code
DSI  
Date Received 12/23/2010
Decision Date 05/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Clinical Trials NCT00680927
Reviewed by Third Party No

Combination Product

No