The following data is part of a premarket notification filed by Canon, Inc. with the FDA for Non-contact Tonometer T-2.
| Device ID | K943939 |
| 510k Number | K943939 |
| Device Name: | NON-CONTACT TONOMETER T-2 |
| Classification | Tonometer, Ac-powered |
| Applicant | CANON, INC. 30-2 SHIMOMARUKO 3-CHOME Ohta-ku, Tokyo, Japan, JP 146 |
| Contact | H Uchii |
| Correspondent | H Uchii CANON, INC. 30-2 SHIMOMARUKO 3-CHOME Ohta-ku, Tokyo, Japan, JP 146 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-12 |
| Decision Date | 1995-05-12 |