Applanation tonometer AT-2
FDA 510(k) K182491 · Takagi Seiko Co., Ltd.
510(k) numberK182491
Submission
- Device name
- Applanation tonometer AT-2
- Applicant
- Takagi Seiko Co., Ltd.
Nakano-Shi, JP - Received
- September 11, 2018
- Decision date
- December 10, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HKY – Tonometer, Manual
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1930
- Specialty
- Ophthalmic
Other 510(k)s with product code HKY
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|---|---|---|---|
| K241447 | iCare ST500 (TA04)HKY · Traditional | Icare Finland OY | 09/27/2024SE |
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)HKY · Traditional | Reichert, Inc. | 05/01/2024SE |
| K234037 | CATS-L Tonometer PrismHKY · Special | Cats Tonometer, LLC | 02/09/2024SE |
| K232143 | Applanation Tonometer HT-5000HKY · Traditional | Huvitz Co., Ltd. | 10/23/2023SE |
| K220852 | iCare IC200HKY · Traditional | Icare Finland OY | 10/06/2022SE |
| K211355 | iCare HOME2HKY · Traditional | Icare Finland OY | 01/25/2022SE |
| K203850 | CATS®-D Tonometer PrismHKY · Traditional | Cats Tonometer, LLC | 06/14/2021SE |
| K200966 | Icare HOME TonometerHKY · Special | Icare Finland OY | 05/07/2020SE |
| K190316 | Icare ic200HKY · Traditional | Icare Finland OY | 01/14/2020SE |
| K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-QHKY · Traditional | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 12/19/2019SE |
More from Chongqing Sunkingdom Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K172728 | Applanation tonometer AT-1HKY · Traditional | 10/17/2017SE |
| K162636 | Marco Ultra M3, Marco Ultra M4HJO · Traditional | 04/14/2017SE |
| K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscopeHJO · Traditional | 05/26/2016SE |
| K063352 | Ellex Slit Lamp, Model 30XLHJO · Traditional | 03/13/2007SE |
Questions and answers
When was Applanation tonometer AT-2 cleared by the FDA?
Applanation tonometer AT-2 (K182491) received a 510(k) decision of Substantially Equivalent on December 10, 2018, 90 days after the submission was received.
What is the product code of K182491?
The FDA product code is HKY – Tonometer, Manual, a Class II (moderate risk) device regulated under 21 CFR 886.1930.