Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q— 510(k) K191314

Name: FDA 510(k) clearance K191314
Creator: U.S. Food and Drug Administration
Published: 2019-12-19

Substantially Equivalent

Chongqing Sunkingdom Medical Instrument Co., Ltd.

FDA 510(k) clearance K191314 for Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q, Substantially Equivalent on 2019-12-19. Applicant: Chongqing Sunkingdom Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Chongqing Sunkingdom Medical Instrument Co., Ltd.
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2019-05-15
Decision date: 2019-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chongqing, CN

Download summary PDF View on FDA.gov ↗

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