Topcon Computerized Tonometer CT-10

FDA 510(k) K871335 · Topcon Instrument Corporation of America

Substantially Equivalent

510(k) numberK871335

Submission

Device name
Topcon Computerized Tonometer CT-10
Applicant
Topcon Instrument Corporation of America
Paramus, NJ, US
Received
April 3, 1987
Decision date
May 18, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Topcon Computerized Tonometer CT-10 cleared by the FDA?

Topcon Computerized Tonometer CT-10 (K871335) received a 510(k) decision of Substantially Equivalent on May 18, 1987, 45 days after the submission was received.

What is the product code of K871335?

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