The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Schepens-yoshida Video Binocular Indirect Ophthalmscope.
| Device ID | K951728 |
| 510k Number | K951728 |
| Device Name: | SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
| Contact | Roger R O'brien |
| Correspondent | Roger R O'brien MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-13 |
| Decision Date | 1997-03-19 |