FDA 510(k)

NPメディカル nCompass エクステンションセットおよび安定基盤

K番号: K221518 · 2022-11-03

決定日2022-11-03

製品コードFPA

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

NP Medical nCompass Extension Set with Stabilizing Base is the device name listed in this FDA 510(k) record. The listed applicant is Np Medical. It received FDA 510(k) clearance on 2022-11-03 under 510(k) number K221518. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the NP Medical nCompass Extension Set with Stabilizing Base?

NP Medical nCompass Extension Set with Stabilizing Base is a medical device that received FDA 510(k) clearance on 2022-11-03. The listed applicant is Np Medical. The 510(k) number is K221518.

When did NP Medical nCompass Extension Set with Stabilizing Base receive FDA 510(k) clearance?

NP Medical nCompass Extension Set with Stabilizing Base received FDA 510(k) clearance on 2022-11-03, under 510(k) number K221518.

Who is the listed applicant for NP Medical nCompass Extension Set with Stabilizing Base?

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

What is the FDA product code for NP Medical nCompass Extension Set with Stabilizing Base?

The FDA product code for NP Medical nCompass Extension Set with Stabilizing Base is FPA.

申請者としてNp Medicalを記載するその他の記録

K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]

公式ソース

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