Corvis ST

FDA 510(k) K113066 · Oculus Optikgerate GmbH

Substantially Equivalent

510(k) numberK113066

Submission

Device name
Corvis ST
Applicant
Oculus Optikgerate GmbH
Wetzlar, DE
Received
October 17, 2011
Decision date
November 8, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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 Corvis ST cleared by the FDA?

Corvis ST (K113066) received a 510(k) decision of Substantially Equivalent on November 8, 2012, 388 days after the submission was received.

What is the product code of K113066?

The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.