The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon Tx-10 Tonometer.
| Device ID | K963079 |
| 510k Number | K963079 |
| Device Name: | CANON TX-10 TONOMETER |
| Classification | Tonometer, Ac-powered |
| Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Contact | Glenn Impal |
| Correspondent | Glenn Impal CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-07 |
| Decision Date | 1997-03-03 |
| Summary: | summary |