The following data is part of a premarket notification filed by Optikon Oftalmologia Spa with the FDA for Perikon Pcl 90.
| Device ID | K922294 |
| 510k Number | K922294 |
| Device Name: | PERIKON PCL 90 |
| Classification | Perimeter, Automatic, Ac-powered |
| Applicant | OPTIKON OFTALMOLOGIA SPA 12014 MILLRIDEGE CIRCLE Sandy, UT 84094 |
| Contact | Charles W Hutchins |
| Correspondent | Charles W Hutchins OPTIKON OFTALMOLOGIA SPA 12014 MILLRIDEGE CIRCLE Sandy, UT 84094 |
| Product Code | HPT |
| CFR Regulation Number | 886.1605 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-15 |
| Decision Date | 1993-01-28 |