FDA 510(k)

膀胱掃描儀（型號：PadScan DS3、PadScan Z3、PadScan Z5）

K 號：K171528 · 2018-01-24

決定日期2018-01-24

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) is the device name listed in this FDA 510(k) record. The listed applicant is Avantsonic Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-01-24 under 510(k) number K171528. 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 (model: PadScan DS3, PadScan Z3, PadScan Z5)?

Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) is a medical device that received FDA 510(k) clearance on 2018-01-24. The listed applicant is Avantsonic Technology Co., Ltd.. The 510(k) number is K171528.

When did Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) receive FDA 510(k) clearance?

Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) received FDA 510(k) clearance on 2018-01-24, under 510(k) number K171528.

Who is the listed applicant for Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)?

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

What is the FDA product code for Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)?

The FDA product code for Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) is IYO.

其他以 Avantsonic 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。

K230986膀胱掃描儀

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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