The following data is part of a premarket notification filed by Nidek Co., Ltd with the FDA for Microperimeter Mp-3, Microperimeter Mp-3 Type S.
| Device ID | K190198 |
| 510k Number | K190198 |
| Device Name: | Microperimeter MP-3, Microperimeter MP-3 Type S |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Nidek Co., Ltd 34-14 Maehama, Hiroishi-cho Gamagori, JP 443-0038 |
| Contact | Mizuno Yoneji |
| Correspondent | Enrico Bisson Nidek Technologies Srl Via Dell'Artigianato, 6/A Albignasego, IT 35020 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-04 |
| Decision Date | 2019-04-01 |