FDA 510(k)

想像式超音波墊及蓋

K 號：K190802 · 2019-05-24

決定日期2019-05-24

產品代碼ITX

諮詢委員會RA

決定相當於

器材摘要

Envision ultrasound pad and cover is the device name listed in this FDA 510(k) record. The listed applicant is Civco Medical Solutions. It received FDA 510(k) clearance on 2019-05-24 under 510(k) number K190802. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Envision ultrasound pad and cover?

Envision ultrasound pad and cover is a medical device that received FDA 510(k) clearance on 2019-05-24. The listed applicant is Civco Medical Solutions. The 510(k) number is K190802.

When did Envision ultrasound pad and cover receive FDA 510(k) clearance?

Envision ultrasound pad and cover received FDA 510(k) clearance on 2019-05-24, under 510(k) number K190802.

Who is the listed applicant for Envision ultrasound pad and cover?

The FDA 510(k) record lists Civco Medical Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Envision ultrasound pad and cover?

The FDA product code for Envision ultrasound pad and cover is ITX.

其他以 Civco Medical Solutions 為申請人之記錄

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K233109TP Pivot Pro™ 穿刺導引器

相關器械（代碼：ITX）

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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