Computon(R)
FDA 510(k) K863200 · Optical Radiation Corp.
510(k) numberK863200
Submission
- Device name
- Computon(R)
- Applicant
- Optical Radiation Corp.
Azusa, CA, US - Received
- August 19, 1986
- Decision date
- September 3, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HKX – Tonometer, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1930
- Specialty
- Ophthalmic
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| K180820 | Tono Vue Non-Contact TonometerHKX · Traditional | Crystalvue Medical Corporation | 12/14/2018SE |
| K162067 | VX130 Ophthalmic Diagnostic DeviceHKX · Traditional | Luneau Sas | 04/24/2017SE |
| K143086 | VX120 Ophthalmic Diagnostic DeviceHKX · Traditional | Luneau Sas | 06/01/2015SE |
| K113066 | Corvis STHKX · Traditional | Oculus Optikgerate GmbH | 11/08/2012SE |
| K111710 | Full Auto Tonometer Model TX-20HKX · Special | Canon Inc. -Medical Equipment Group | 09/20/2011SE |
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Questions and answers
When was Computon(R) cleared by the FDA?
Computon(R) (K863200) received a 510(k) decision of Substantially Equivalent on September 3, 1986, 15 days after the submission was received.
What is the product code of K863200?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.