Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q

FDA 510(k) K191314 · Chongqing Sunkingdom Medical Instrument Co., Ltd.

Substantially Equivalent

510(k) numberK191314

Submission

Device name
Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
Applicant
Chongqing Sunkingdom Medical Instrument Co., Ltd.
Chongqing, CN
Received
May 15, 2019
Decision date
December 19, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HKY – Tonometer, Manual
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1930
Specialty
Ophthalmic

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Questions and answers

When was Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q cleared by the FDA?

Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q (K191314) received a 510(k) decision of Substantially Equivalent on December 19, 2019, 218 days after the submission was received.

What is the product code of K191314?

The FDA product code is HKY – Tonometer, Manual, a Class II (moderate risk) device regulated under 21 CFR 886.1930.