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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 the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Sunkingdom Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-01-09 under 510(k) 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. The listed applicant is Chongqing Sunkingdom Medical Instrument Co., Ltd.. The 510(k) number is K222787.

When did Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P receive FDA 510(k) clearance?

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 510(k) number K222787.

Who is the listed applicant for Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P?

The FDA 510(k) record lists Chongqing Sunkingdom Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Chongqing Sunkingdom Medical Instrument Co., Ltd. as applicant

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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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