Cleared Traditional

Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P

K222787 · Chongqing Sunkingdom Medical Instrument Co., Ltd. · Radiology

Jan 2023

Decision

116d

Days

Class 2

Risk

About This 510(k) Submission

K222787 is an FDA 510(k) clearance for the Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Chongqing Sunkingdom Medical Instrument Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on January 9, 2023, 116 days after receiving the submission on September 15, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K222787 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 2022
Decision Date	January 09, 2023
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF