Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P— 510(k) K222787

Name: FDA 510(k) clearance K222787
Creator: U.S. Food and Drug Administration
Published: 2023-01-09

Substantially Equivalent

Chongqing Sunkingdom Medical Instrument Co., Ltd.

FDA 510(k) clearance K222787 for Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P, Substantially Equivalent on 2023-01-09. Applicant: Chongqing Sunkingdom Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Chongqing Sunkingdom Medical Instrument Co., Ltd.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2022-09-15
Decision date: 2023-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chongqing, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.