BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT


Device Classification Name

detector and alarm, arrhythmia

510(k) Number K121197
Device Name BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
Applicant
PREVENTICE, INC.
2765 commerce drive nw
suite 220
rochester, 
MN 
55901

Applicant Contact drew palin
Correspondent
PREVENTICE, INC.
2765 commerce drive nw
suite 220
rochester, 
MN 
55901

Correspodent Contact drew palin
Regulation Number 870.1025
Classification Product Code
DSI  
Date Received 04/19/2012
Decision Date 08/10/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No