The following data is part of a premarket notification filed by Tomey Corporation with the FDA for Non-contact Tonometer, Model Ft-1000.
| Device ID | K073087 |
| 510k Number | K073087 |
| Device Name: | NON-CONTACT TONOMETER, MODEL FT-1000 |
| Classification | Tonometer, Ac-powered |
| Applicant | TOMEY CORPORATION 2-17-6 AKENBONO-CHO TACHIKAWA-SHI Tokyo, JP 190-0012 |
| Contact | Koji Kubo |
| Correspondent | Koji Kubo TOMEY CORPORATION 2-17-6 AKENBONO-CHO TACHIKAWA-SHI Tokyo, JP 190-0012 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-01 |
| Decision Date | 2008-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582273612167 | K073087 | 000 |
| 04582273612150 | K073087 | 000 |
| 04582273611740 | K073087 | 000 |
| 04582273600263 | K073087 | 000 |