FDA 510(k)

口袋式超音波系統（C10）

K 號：K231354 · 2023-12-20

申請人Beijing Konted Medical Technology Co.,Ltd

決定日期2023-12-20

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Pocket Ultrasound System (C10) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Konted Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K231354. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pocket Ultrasound System (C10)?

Pocket Ultrasound System (C10) is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Beijing Konted Medical Technology Co.,Ltd. The 510(k) number is K231354.

When did Pocket Ultrasound System (C10) receive FDA 510(k) clearance?

Pocket Ultrasound System (C10) received FDA 510(k) clearance on 2023-12-20, under 510(k) number K231354.

Who is the listed applicant for Pocket Ultrasound System (C10)?

FDA 510(k) 記錄將北京康特醫療科技有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Pocket Ultrasound System (C10)?

The FDA product code for Pocket Ultrasound System (C10) is IYN.

其他以 Beijing Konted Medical Technology 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。

K261081口袋式超音波系統（C10MTpro、C10MXpro、C10MSpro、C10MBpro、C10MRpro）K241979口袋式超音波系統（C10、C10TX、C10RL、C10RLpro）

相關器械（代碼：IYN）

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。

官方來源

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