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510(k) K222787

Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P by Chongqing Sunkingdom Medical Instrument Co., Ltd. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2023
Date Received
September 15, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Chongqing Sunkingdom Medical Instrument Co., Ltd.

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  • K182306 — Sunkingdom Slit Lamp (November 22, 2018)

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