The following data is part of a premarket notification filed by Neitz Instruments Company, Ltd. with the FDA for Indirect Ophthalmoscope Video System Io0 A Tv.
| Device ID | K951338 |
| 510k Number | K951338 |
| Device Name: | INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | NEITZ INSTRUMENTS COMPANY, LTD. 36-13, WAKAMATSU-CHO, SHINJUKU-KU Tokyo, JP 162-0056 |
| Contact | Yasuo Kawano |
| Correspondent | Yasuo Kawano NEITZ INSTRUMENTS COMPANY, LTD. 36-13, WAKAMATSU-CHO, SHINJUKU-KU Tokyo, JP 162-0056 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-24 |
| Decision Date | 1995-04-07 |