FDA 510(k)

範圍 BUDDY PLUS 絞道清潔輔助設備

K 號：K213833 · 2022-01-14

決定日期2022-01-14

產品代碼FEB

諮詢委員會GU

決定相當於

器材摘要

SCOPE BUDDY PLUS Endoscope Flushing Aid is the device name listed in this FDA 510(k) record. The listed applicant is Medivators, Inc.. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K213833. 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 SCOPE BUDDY PLUS Endoscope Flushing Aid?

SCOPE BUDDY PLUS Endoscope Flushing Aid is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Medivators, Inc.. The 510(k) number is K213833.

When did SCOPE BUDDY PLUS Endoscope Flushing Aid receive FDA 510(k) clearance?

SCOPE BUDDY PLUS Endoscope Flushing Aid received FDA 510(k) clearance on 2022-01-14, under 510(k) number K213833.

Who is the listed applicant for SCOPE BUDDY PLUS Endoscope Flushing Aid?

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

What is the FDA product code for SCOPE BUDDY PLUS Endoscope Flushing Aid?

The FDA product code for SCOPE BUDDY PLUS Endoscope Flushing Aid is FEB.

其他以 Medivators, Inc. 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。

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官方來源

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