The following data is part of a premarket notification filed by Medical Research Laboratories, Inc. with the FDA for 450sll Defibrillator.
Device ID | K874204 |
510k Number | K874204 |
Device Name: | 450SLL DEFIBRILLATOR |
Classification | Dc-defibrillator, Low-energy, (including Paddles) |
Applicant | MEDICAL RESEARCH LABORATORIES, INC. 6457 W. HOWARD ST. Niles, IL 60648 |
Contact | Dilip Mehta |
Correspondent | Dilip Mehta MEDICAL RESEARCH LABORATORIES, INC. 6457 W. HOWARD ST. Niles, IL 60648 |
Product Code | LDD |
CFR Regulation Number | 870.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-15 |
Decision Date | 1988-01-28 |