Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K002232 |
Device Name |
AEDEFIBRILLATOR |
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 |
|
Subsequent Product Codes |
|
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
|
|
|