The following data is part of a premarket notification filed by Medical Research Laboratories, Inc. with the FDA for 360 Slx Advisory Defibrillator.
Device ID | K935922 |
510k Number | K935922 |
Device Name: | 360 SLX ADVISORY DEFIBRILLATOR |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | MEDICAL RESEARCH LABORATORIES, INC. 1000 ASBURY DR. NO.17 Buffalo Grove, IL 60089 |
Contact | Dilip Mehta |
Correspondent | Dilip Mehta MEDICAL RESEARCH LABORATORIES, INC. 1000 ASBURY DR. NO.17 Buffalo Grove, IL 60089 |
Product Code | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-13 |
Decision Date | 1994-12-22 |