FDA 510(k)

Site~Rite 8 超聲系統搭配 Cue 尖針追蹤系統及 Pinpoint GT 尖針技術

K 號：K182281 · 2018-10-24

決定日期2018-10-24

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech is the device name listed in this FDA 510(k) record. The listed applicant is C. R. Bard. It received FDA 510(k) clearance on 2018-10-24 under 510(k) number K182281. 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 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech?

Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is C. R. Bard. The 510(k) number is K182281.

When did Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech receive FDA 510(k) clearance?

Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech received FDA 510(k) clearance on 2018-10-24, under 510(k) number K182281.

Who is the listed applicant for Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech?

The FDA 510(k) record lists C. R. Bard as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech?

The FDA product code for Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech is IYO.

其他以 C. R. Bard 為申請人之記錄

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相關器械（代碼：IYO）

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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