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FDA 510(k)

Sunkingdom眼科超音波檢查儀器 SK-3000A、SK-3000B、SK-3000C、SK-2000AP、SK-2000A、SK-2000P

K 號：K222787 · 2023-01-09

申請人Chongqing Sunkingdom Medical Instrument Co., Ltd.
決定日期2023-01-09
產品代碼IYO
諮詢委員會RA
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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其他以 Chongqing Sunkingdom Medical Instrument Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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