FDA 510(k)

MHC標準およびNRFitチップ注射器

K番号: K171131 · 2017-11-08

決定日2017-11-08

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

MHC Standard and NRFit Tip Syringes is the device name listed in this FDA 510(k) record. The listed applicant is Mazza Healthcare, LLC. It received FDA 510(k) clearance on 2017-11-08 under 510(k) number K171131. 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 MHC Standard and NRFit Tip Syringes?

MHC Standard and NRFit Tip Syringes is a medical device that received FDA 510(k) clearance on 2017-11-08. The listed applicant is Mazza Healthcare, LLC. The 510(k) number is K171131.

When did MHC Standard and NRFit Tip Syringes receive FDA 510(k) clearance?

MHC Standard and NRFit Tip Syringes received FDA 510(k) clearance on 2017-11-08, under 510(k) number K171131.

Who is the listed applicant for MHC Standard and NRFit Tip Syringes?

The FDA 510(k) record lists Mazza Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MHC Standard and NRFit Tip Syringes?

The FDA product code for MHC Standard and NRFit Tip Syringes is FMF.

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MHC標準およびNRFitチップ注射器

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：FMF）

公式ソース