The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Ocs 100 (ocular Comparator System).
| Device ID | K874220 |
| 510k Number | K874220 |
| Device Name: | OCS 100 (OCULAR COMPARATOR SYSTEM) |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | OCULAR INSTRUMENTS, INC. 12100 NORTHUP WAY SUITE D Bellevue, WA 98005 |
| Contact | Tamsin J Erickson |
| Correspondent | Tamsin J Erickson OCULAR INSTRUMENTS, INC. 12100 NORTHUP WAY SUITE D Bellevue, WA 98005 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-16 |
| Decision Date | 1987-12-23 |