The following data is part of a premarket notification filed by Medical Research Laboratories, Inc. with the FDA for Mrl Oximeter.
Device ID | K882664 |
510k Number | K882664 |
Device Name: | MRL OXIMETER |
Classification | Oximeter |
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 | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-27 |
Decision Date | 1988-09-16 |