The following data is part of a premarket notification filed by Medical Research Laboratories, Inc. with the FDA for Aedefibrillator.
| Device ID | K002232 |
| 510k Number | K002232 |
| Device Name: | AEDEFIBRILLATOR |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | MEDICAL RESEARCH LABORATORIES, INC. 1000 ASBURY DR. NO.17 Buffalo Grove, IL 60089 |
| Contact | Joel Orlinsky |
| Correspondent | Joel Orlinsky MEDICAL RESEARCH LABORATORIES, INC. 1000 ASBURY DR. NO.17 Buffalo Grove, IL 60089 |
| Product Code | MKJ |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DRT |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-24 |
| Decision Date | 2000-12-06 |