FDA 510(k)

皮下注射針筒および針

K番号: K222925 · 2023-07-18

決定日2023-07-18

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

Hypodermic Syringes & Needle is the device name listed in this FDA 510(k) record. The listed applicant is Lifelong Meditech Private Limited. It received FDA 510(k) clearance on 2023-07-18 under 510(k) number K222925. 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 Hypodermic Syringes & Needle?

Hypodermic Syringes & Needle is a medical device that received FDA 510(k) clearance on 2023-07-18. The listed applicant is Lifelong Meditech Private Limited. The 510(k) number is K222925.

When did Hypodermic Syringes & Needle receive FDA 510(k) clearance?

Hypodermic Syringes & Needle received FDA 510(k) clearance on 2023-07-18, under 510(k) number K222925.

Who is the listed applicant for Hypodermic Syringes & Needle?

The FDA 510(k) record lists Lifelong Meditech Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hypodermic Syringes & Needle?

The FDA product code for Hypodermic Syringes & Needle is FMF.

申請者としてLifelong Meditech Private Limitedを記載するその他の記録

K210103SAFETYWAY、LIFELONG PREMIUM、LIFELONG MATRIX

公式ソース

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