The following data is part of a premarket notification filed by Topcon Instrument Corporation Of America with the FDA for Topcon Computerized Tonometer Ct-10.
| Device ID | K871335 |
| 510k Number | K871335 |
| Device Name: | TOPCON COMPUTERIZED TONOMETER CT-10 |
| Classification | Tonometer, Ac-powered |
| Applicant | TOPCON INSTRUMENT CORPORATION OF AMERICA 65 WEST CENTURY RD. Paramus, NJ 07652 |
| Contact | Gordon W Siteman |
| Correspondent | Gordon W Siteman TOPCON INSTRUMENT CORPORATION OF AMERICA 65 WEST CENTURY RD. Paramus, NJ 07652 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-03 |
| Decision Date | 1987-05-18 |