FDA 510(k)

Aspire メカニカル吸引器 G

K番号: K200629 · 2020-05-29

決定日2020-05-29

製品コードFMF

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

Aspire Mechanical Aspirator G is the device name listed in this FDA 510(k) record. The listed applicant is Control Medical Technology. It received FDA 510(k) clearance on 2020-05-29 under 510(k) number K200629. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Aspire Mechanical Aspirator G?

Aspire Mechanical Aspirator G is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is Control Medical Technology. The 510(k) number is K200629.

When did Aspire Mechanical Aspirator G receive FDA 510(k) clearance?

Aspire Mechanical Aspirator G received FDA 510(k) clearance on 2020-05-29, under 510(k) number K200629.

Who is the listed applicant for Aspire Mechanical Aspirator G?

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

What is the FDA product code for Aspire Mechanical Aspirator G?

The FDA product code for Aspire Mechanical Aspirator G is FMF.

申請者としてControl Medical Technologyを記載するその他の記録

K200871Aspire MAX 7 - 11F メカニカル血栓除去システムおよびAspire メカニカル吸引器

公式ソース

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