The following data is part of a premarket notification filed by Mentor O & O, Inc. with the FDA for Binocular Indirect Ophthalmoscope.
| Device ID | K843304 |
| 510k Number | K843304 |
| Device Name: | BINOCULAR INDIRECT OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | MENTOR O & O, INC. SOUTH SHORE PARK Hingham, MA 02043 |
| Contact | David M Link |
| Correspondent | David M Link MENTOR O & O, INC. SOUTH SHORE PARK Hingham, MA 02043 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-23 |
| Decision Date | 1984-11-21 |