Kowa KT-800
FDA 510(k) K053444 · Kowa Co. , Ltd.
510(k) numberK053444
Submission
- Device name
- Kowa KT-800
- Applicant
- Kowa Co. , Ltd.
Mie-Ken, JP - Received
- December 9, 2005
- Decision date
- June 9, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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Questions and answers
When was Kowa KT-800 cleared by the FDA?
Kowa KT-800 (K053444) received a 510(k) decision of Substantially Equivalent on June 9, 2006, 182 days after the submission was received.
What is the product code of K053444?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.