Full Auto Tonometer Model TX-20
FDA 510(k) K111710 · Canon Inc. -Medical Equipment Group
510(k) numberK111710
Submission
- Device name
- Full Auto Tonometer Model TX-20
- Applicant
- Canon Inc. -Medical Equipment Group
Tachikawa-Shi, Tokyo, JP - Received
- June 20, 2011
- Decision date
- September 20, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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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| K102013 | Digital Retinal CameraHKI · Special | 10/29/2010SE |
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Questions and answers
When was Full Auto Tonometer Model TX-20 cleared by the FDA?
Full Auto Tonometer Model TX-20 (K111710) received a 510(k) decision of Substantially Equivalent on September 20, 2011, 92 days after the submission was received.
What is the product code of K111710?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.