HEART SYNC, MODELS C-100 AND T-100


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K080421
Device Name HEART SYNC, MODELS C-100 AND T-100
Applicant
HEART SYNC LLC
5643 plymouth road
ann arbor, 
MI 
48105

Applicant Contact stephen shulman
Regulation Number 870.5310
Classification Product Code
MKJ  
Subsequent Product Code
MLN  
Date Received 02/15/2008
Decision Date 02/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls