The following data is part of a premarket notification filed by Medical Instrument Research Assoc., Inc. with the FDA for Blue Field Entoptoscope Bfe100.
| Device ID | K791510 |
| 510k Number | K791510 |
| Device Name: | BLUE FIELD ENTOPTOSCOPE BFE100 |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | MEDICAL INSTRUMENT RESEARCH ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-02 |
| Decision Date | 1979-12-11 |