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FDA 510(k)

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

K-Number: K222787 · 2023-01-09

ApplicantChongqing Sunkingdom Medical Instrument Co., Ltd.
Decision Date2023-01-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P is a medical device manufactured by Chongqing Sunkingdom Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-01-09 under approval number K222787. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P?

Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P is a medical device that received FDA 510(k) clearance on 2023-01-09. It is manufactured by Chongqing Sunkingdom Medical Instrument Co., Ltd.. The 510(k) number is K222787.

When was Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P approved by the FDA?

Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P received FDA 510(k) clearance on 2023-01-09, under approval number K222787.

What company makes Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P?

Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P is manufactured by Chongqing Sunkingdom Medical Instrument Co., Ltd..

What is the FDA product code for Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P?

The FDA product code for Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P is IYO.

Related Clinical Trials

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

K182306Sunkingdom Slit Lamp K191314Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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