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FDA 510(k)

膀胱掃描儀

K 號:K153581 · 2016-04-08

決定日期2016-04-08
產品代碼IYO
諮詢委員會RA
決定相當於

器材摘要

Bladder Scanner is the device name listed in this FDA 510(k) record. The listed applicant is Caresono Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K153581. 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 Bladder Scanner?

Bladder Scanner is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Caresono Technology Co., Ltd.. The 510(k) number is K153581.

When did Bladder Scanner receive FDA 510(k) clearance?

Bladder Scanner received FDA 510(k) clearance on 2016-04-08, under 510(k) number K153581.

Who is the listed applicant for Bladder Scanner?

The FDA 510(k) record lists Caresono Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bladder Scanner?

The FDA product code for Bladder Scanner is IYO.

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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。

官方來源

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