FDA 510(k)

エリプスサプルメントインストルメントトレイ

K番号: K151594 · 2016-01-25

決定日2016-01-25

製品コードKCT

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

Ellipse Supplemental Instrument Trays is the device name listed in this FDA 510(k) record. The listed applicant is Ellipse Technologies, Incorporated. It received FDA 510(k) clearance on 2016-01-25 under 510(k) number K151594. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Ellipse Supplemental Instrument Trays?

Ellipse Supplemental Instrument Trays is a medical device that received FDA 510(k) clearance on 2016-01-25. The listed applicant is Ellipse Technologies, Incorporated. The 510(k) number is K151594.

When did Ellipse Supplemental Instrument Trays receive FDA 510(k) clearance?

Ellipse Supplemental Instrument Trays received FDA 510(k) clearance on 2016-01-25, under 510(k) number K151594.

Who is the listed applicant for Ellipse Supplemental Instrument Trays?

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

What is the FDA product code for Ellipse Supplemental Instrument Trays?

The FDA product code for Ellipse Supplemental Instrument Trays is KCT.

申請者としてEllipse Technologies, Incorporatedを記載するその他の記録

K160267PRECICE外傷ネイルシステム

公式ソース

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