The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Microperimeter Mp-3.
| Device ID | K152729 |
| 510k Number | K152729 |
| Device Name: | MICROPERIMETER MP-3 |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | NIDEK CO., LTD. 34-14 MAEHAMA, HIROISHI-CHO Gamagori, JP 443-0038 |
| Contact | Yoneji Mizuno |
| Correspondent | Enrico Bisson NIDEK TECHNOLOGIES SRL VIA DELL' ARTIGIANATO, 6/A Albignasego (padova), 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 | 2015-09-22 |
| Decision Date | 2016-06-06 |
| Summary: | summary |