The following data is part of a premarket notification filed by Canon, Inc.-utsunomiya Optical Products Operation with the FDA for Canon Full Auto Tonometer Tx-f.
| Device ID | K023816 |
| 510k Number | K023816 |
| Device Name: | CANON FULL AUTO TONOMETER TX-F |
| Classification | Tonometer, Ac-powered |
| Applicant | CANON, INC.-UTSUNOMIYA OPTICAL PRODUCTS OPERATION ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Contact | Sheila Driscoll |
| Correspondent | Kent Donohue UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-11-15 |
| Decision Date | 2002-11-26 |
| Summary: | summary |