The following data is part of a premarket notification filed by Medical Research Laboratories, Inc. with the FDA for Mrl Blood Pressure Monitor.
Device ID | K885191 |
510k Number | K885191 |
Device Name: | MRL BLOOD PRESSURE MONITOR |
Classification | System, Measurement, Blood-pressure, Non-invasive |
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 | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-16 |
Decision Date | 1989-05-23 |