The following data is part of a premarket notification filed by Coburn Optical Ind., Inc. with the FDA for Automated Perimeters.
Device ID | K803159 |
510k Number | K803159 |
Device Name: | AUTOMATED PERIMETERS |
Classification | Perimeter, Automatic, Ac-powered |
Applicant | COBURN OPTICAL IND., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HPT |
CFR Regulation Number | 886.1605 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-12-08 |
Decision Date | 1981-02-04 |