The following data is part of a premarket notification filed by Medical Research Laboratories, Inc. with the FDA for Dpd Defibrillator.
Device ID | K952085 |
510k Number | K952085 |
Device Name: | DPD DEFIBRILLATOR |
Classification | Dc-defibrillator, Low-energy, (including Paddles) |
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 | LDD |
CFR Regulation Number | 870.5300 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-03 |
Decision Date | 1995-06-05 |