The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Dorc Lightweight Binocular Ophthalmoscop.
| Device ID | K830215 |
| 510k Number | K830215 |
| Device Name: | DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | JEDMED INSTRUMENT CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-24 |
| Decision Date | 1983-03-09 |