DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K121853
Device Name DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
Applicant
DEFIBTECH, LLC
741 boston post road
guilford, 
CT 
06437

Applicant Contact ed horton
Correspondent
DEFIBTECH, LLC
741 boston post road
guilford, 
CT 
06437

Correspodent Contact ed horton
Regulation Number 870.5310
Classification Product Code
MKJ  
Date Received 06/25/2012
Decision Date 12/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No