Kowa Hand-Held Applanation Tonometer HA-1
FDA 510(k) K960924 · Kowa Optimed, Inc.
510(k) numberK960924
Submission
- Device name
- Kowa Hand-Held Applanation Tonometer HA-1
- Applicant
- Kowa Optimed, Inc.
Washington, DC, US - Received
- March 6, 1996
- Decision date
- June 4, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HKY – Tonometer, Manual
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1930
- Specialty
- Ophthalmic
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| 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 |
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| K955442 | Kowa SC-1200 Photo Slit Lamp SystemHKI · Traditional | 01/03/1996SE |
| K954781 | Kowa Genesis Hand-Held Fundus CameraHKI · Traditional | 12/01/1995SE |
| K954780 | Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500CHKI · Traditional | 12/01/1995SE |
| K954782 | Kowa Portable Slit Lamp SL-14 & SL-14BHJO · Traditional | 11/24/1995SE |
| K913852 | Laser Flare MeterHJO · Traditional | 02/07/1992SE |
| K880920 | Laser Flare Cell Meter FC-1000HJO · Traditional | 09/27/1988SE |
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Questions and answers
When was Kowa Hand-Held Applanation Tonometer HA-1 cleared by the FDA?
Kowa Hand-Held Applanation Tonometer HA-1 (K960924) received a 510(k) decision of Substantially Equivalent on June 4, 1996, 90 days after the submission was received.
What is the product code of K960924?
The FDA product code is HKY – Tonometer, Manual, a Class II (moderate risk) device regulated under 21 CFR 886.1930.