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 |