Keeler Disposable Tonomate, Keeler Disposable Tonomate, Box of 100
FDA 510(k) K152644 · Keeler Limited
510(k) numberK152644
Submission
- Device name
- Keeler Disposable Tonomate, Keeler Disposable Tonomate, Box of 100
- Applicant
- Keeler Limited
Windsor, GB - Received
- September 16, 2015
- Decision date
- December 31, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K151394 | Keeler Slit LampHJO · Traditional | 09/10/2015SE |
| K142179 | D-Kat Z-YpeHKY · Special | 09/17/2014SE |
| K140451 | Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp H-Series…HJO · Traditional | 07/11/2014SE |
| K140450 | Keeler Kapture SoftwareHKI · Traditional | 06/17/2014SE |
| K133234 | T-Type D-Kat, R-Type D-KatHKY · Traditional | 02/21/2014SE |
| K131787 | Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo ProbesHRN · Special | 12/23/2013SE |
| K131589 | Keeler Slit Lamp H-SeriesHJO · Abbreviated | 06/27/2013SE |
| K093445 | Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat)HKY · Abbreviated | 01/19/2010SE |
Questions and answers
When was Keeler Disposable Tonomate, Keeler Disposable Tonomate, Box of 100 cleared by the FDA?
Keeler Disposable Tonomate, Keeler Disposable Tonomate, Box of 100 (K152644) received a 510(k) decision of Substantially Equivalent on December 31, 2015, 106 days after the submission was received.
What is the product code of K152644?
The FDA product code is HKY – Tonometer, Manual, a Class II (moderate risk) device regulated under 21 CFR 886.1930.