Cleared Traditional

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

K191314 · Chongqing Sunkingdom Medical Instrument Co., Ltd. · Ophthalmic

Dec 2019

Decision

218d

Days

Class 2

Risk

About This 510(k) Submission

K191314 is an FDA 510(k) clearance for the Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q, a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Chongqing Sunkingdom Medical Instrument Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on December 19, 2019, 218 days after receiving the submission on May 15, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number	K191314 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2019
Decision Date	December 19, 2019
Days to Decision	218 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF