Automatic Visual Field Plotter AP-125
FDA 510(k) K961090 · Kowa Optimed, Inc.
510(k) numberK961090
Submission
- Device name
- Automatic Visual Field Plotter AP-125
- Applicant
- Kowa Optimed, Inc.
Washington, DC, US - Received
- March 19, 1996
- Decision date
- June 17, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HPT – Perimeter, Automatic, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1605
- Specialty
- Ophthalmic
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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 |
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Questions and answers
When was Automatic Visual Field Plotter AP-125 cleared by the FDA?
Automatic Visual Field Plotter AP-125 (K961090) received a 510(k) decision of Substantially Equivalent on June 17, 1996, 90 days after the submission was received.
What is the product code of K961090?
The FDA product code is HPT – Perimeter, Automatic, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1605.