FDA 510(k)

Scope-Assist フラッシングシンク

K番号: K162120 · 2017-04-28

決定日2017-04-28

製品コードFEB

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

Scope-Assist Flushing Sink 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 2017-04-28 under 510(k) number K162120. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Scope-Assist Flushing Sink?

Scope-Assist Flushing Sink is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Custom Ultrasonics, Inc.. The 510(k) number is K162120.

When did Scope-Assist Flushing Sink receive FDA 510(k) clearance?

Scope-Assist Flushing Sink received FDA 510(k) clearance on 2017-04-28, under 510(k) number K162120.

Who is the listed applicant for Scope-Assist Flushing Sink?

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 Scope-Assist Flushing Sink?

The FDA product code for Scope-Assist Flushing Sink is FEB.

申請者としてCustom Ultrasonics, Inc.を記載するその他の記録

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