The following data is part of a premarket notification filed by Canon, Inc.-medical Equipment Group with the FDA for Full Auto Tonometer Model Tx-20.
| Device ID | K111710 |
| 510k Number | K111710 |
| Device Name: | FULL AUTO TONOMETER MODEL TX-20 |
| Classification | Tonometer, Ac-powered |
| Applicant | CANON, INC.-MEDICAL EQUIPMENT GROUP C/O COSMOS CORPORATION 3F 2-17-6 AKEBONO-CHO Tachikawa-shi, Tokyo, JP 190-0012 |
| Contact | Koji Kubo |
| Correspondent | Koji Kubo CANON, INC.-MEDICAL EQUIPMENT GROUP C/O COSMOS CORPORATION 3F 2-17-6 AKEBONO-CHO Tachikawa-shi, Tokyo, JP 190-0012 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-20 |
| Decision Date | 2011-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04549292074369 | K111710 | 000 |