The following data is part of a premarket notification filed by Neitz Instruments Company, Ltd. with the FDA for Cataractscreener Ct - S.
| Device ID | K972440 |
| 510k Number | K972440 |
| Device Name: | CATARACTSCREENER CT - S |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | NEITZ INSTRUMENTS COMPANY, LTD. 36-13, WAKAMATSU-CHO, SHINJUKU-KU Tokyo, JP 162-0056 |
| Contact | Masao Sugasawa |
| Correspondent | Masao Sugasawa NEITZ INSTRUMENTS COMPANY, LTD. 36-13, WAKAMATSU-CHO, SHINJUKU-KU Tokyo, JP 162-0056 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-30 |
| Decision Date | 1997-09-30 |