FDA 510(k)

コダマン・シェラス・プラス・エレクトロニック・ツール・キット

K番号: K181902 · 2018-10-25

決定日2018-10-25

製品コードJXG

諮問委員会Please provide the source text to translate.

決定Substantially Equivalent

医療機器の概要

Codman Certas Plus Electronic Tool Kit is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2018-10-25 under 510(k) number K181902. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Codman Certas Plus Electronic Tool Kit?

Codman Certas Plus Electronic Tool Kit is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K181902.

When did Codman Certas Plus Electronic Tool Kit receive FDA 510(k) clearance?

Codman Certas Plus Electronic Tool Kit received FDA 510(k) clearance on 2018-10-25, under 510(k) number K181902.

Who is the listed applicant for Codman Certas Plus Electronic Tool Kit?

The FDA 510(k) record lists Integra Lifesciences Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Codman Certas Plus Electronic Tool Kit?

The FDA product code for Codman Certas Plus Electronic Tool Kit is JXG.

申請者としてIntegra Lifesciences Corp.を記載するその他の記録

K183581コダマンディスポーザブルパーフォレータ K183406CereLink ICPモニター、CereLink ICP延長ケーブル K182265CodMan Certas Plus プログラム可能バルブ

公式ソース

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