AEDEFIBRILLATOR


information about

Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K002232
Device Name AEDEFIBRILLATOR
Original Applicant
MEDICAL RESEARCH LABORATORIES, INC.
1000 asbury dr. no.17
buffalo grove, 
IL 
60089

Original Contact joel orlinsky
Regulation Number 870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
DPS   DRT  
Date Received 07/24/2000
Decision Date 12/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls