The following data is part of a premarket notification filed by Neitz Instruments Company, Ltd. with the FDA for Halogen Ophthalmo-otoscope Set Bx A - 134.
| Device ID | K950797 |
| 510k Number | K950797 |
| Device Name: | HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 |
| Classification | Ophthalmoscope, Battery-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 | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-21 |
| Decision Date | 1995-03-28 |