INFANT/CHILD REDUCED ENERGY ELECTRODES


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K022732
Device Name INFANT/CHILD REDUCED ENERGY ELECTRODES
Original Applicant
MEDTRONIC PHYSIO-CONTROL CORP.
11811 willows rd., n.e.
redmond, 
WA 
98073

Original Contact sherri l pocock
Regulation Number 870.5310
Classification Product Code
MKJ  
Subsequent Product Code
MLN  
Date Received 08/16/2002
Decision Date 12/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No