FDA 510(k)

系統83 Plus 洗淨/消毒機

K 號：K173590 · 2020-03-30

決定日期2020-03-30

產品代碼FEB

諮詢委員會GU

決定相當於

器材摘要

System 83 Plus Washer/Disinfector is the device name listed in this FDA 510(k) record. The listed applicant is Custom Ultrasonics, Inc.. It received FDA 510(k) clearance on 2020-03-30 under 510(k) number K173590. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the System 83 Plus Washer/Disinfector?

System 83 Plus Washer/Disinfector is a medical device that received FDA 510(k) clearance on 2020-03-30. The listed applicant is Custom Ultrasonics, Inc.. The 510(k) number is K173590.

When did System 83 Plus Washer/Disinfector receive FDA 510(k) clearance?

System 83 Plus Washer/Disinfector received FDA 510(k) clearance on 2020-03-30, under 510(k) number K173590.

Who is the listed applicant for System 83 Plus Washer/Disinfector?

The FDA 510(k) record lists Custom Ultrasonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for System 83 Plus Washer/Disinfector?

The FDA product code for System 83 Plus Washer/Disinfector is FEB.

其他以 Custom Ultrasonics, Inc. 為申請人之記錄

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K162120範圍輔助清潔槽

相關器械（代碼：FEB）

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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