Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K021168 |
Device Name |
JUMP START, MODEL 970300 |
Applicant |
MEDICAL RESEARCH LABORATORIES, INC. |
1000 ASBURY DR. NO.17 |
BUFFALO GROVE,
IL
60089
|
|
Applicant Contact |
JOEL ORLINSKY |
Correspondent |
MEDICAL RESEARCH LABORATORIES, INC. |
1000 ASBURY DR. NO.17 |
BUFFALO GROVE,
IL
60089
|
|
Correspondent Contact |
JOEL ORLINSKY |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 04/11/2002 |
Decision Date | 06/26/2002 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|