The following data is part of a premarket notification filed by Takagi Seiko Co., Ltd. with the FDA for Applanation Tonometer At-2.
| Device ID | K182491 |
| 510k Number | K182491 |
| Device Name: | Applanation Tonometer AT-2 |
| Classification | Tonometer, Manual |
| Applicant | Takagi Seiko Co., Ltd. 330-2 Nakano-shi, JP 383-8585 |
| Contact | Shinya Kitamura |
| Correspondent | Shinya Kitamura Takagi Seiko Co., Ltd. 330-2 Nakano-shi, JP 383-8585 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-11 |
| Decision Date | 2018-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560323648526 | K182491 | 000 |
| 04560323648519 | K182491 | 000 |