The following data is part of a premarket notification filed by Nidek Technologies Srl with the FDA for Mp-1 Microperimeter.
| Device ID | K061768 |
| 510k Number | K061768 |
| Device Name: | MP-1 MICROPERIMETER |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | NIDEK TECHNOLOGIES SRL VIA DELL ARTIGIANATO, 6/A Albignasego (padova), IT 35020 |
| Contact | Aldo Cocchiglia |
| Correspondent | Aldo Cocchiglia 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 | 2006-06-23 |
| Decision Date | 2006-09-28 |
| Summary: | summary |