The following data is part of a premarket notification filed by Nidek Technologies Srl with the FDA for Mp-1 Micro Perimeter.
| Device ID | K023719 |
| 510k Number | K023719 |
| Device Name: | MP-1 MICRO PERIMETER |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | NIDEK TECHNOLOGIES SRL VIA REGIA, 88 Vigonza (padova), IT 35010 |
| Contact | Aldo Cocchiglia |
| Correspondent | Mark Job TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-11-05 |
| Decision Date | 2002-12-23 |
| Summary: | summary |