FDA 510(k)

口/経口注射器付ENFitコネクタ

K番号: K211025 · 2021-06-30

申請者Ningbo Tianyi Medical Appliance Co., Ltd.

決定日2021-06-30

製品コードPNR

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

Oral/Enteral Syringe with ENFit connector is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Tianyi Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2021-06-30 under 510(k) number K211025. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Oral/Enteral Syringe with ENFit connector?

Oral/Enteral Syringe with ENFit connector is a medical device that received FDA 510(k) clearance on 2021-06-30. The listed applicant is Ningbo Tianyi Medical Appliance Co., Ltd.. The 510(k) number is K211025.

When did Oral/Enteral Syringe with ENFit connector receive FDA 510(k) clearance?

Oral/Enteral Syringe with ENFit connector received FDA 510(k) clearance on 2021-06-30, under 510(k) number K211025.

Who is the listed applicant for Oral/Enteral Syringe with ENFit connector?

The FDA 510(k) record lists Ningbo Tianyi Medical Appliance Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oral/Enteral Syringe with ENFit connector?

The FDA product code for Oral/Enteral Syringe with ENFit connector is PNR.

申請者としてNingbo Tianyi Medical Appliance Co., Ltd.を記載するその他の記録

K251442天一体外循環血液管路セット（TY-NDEO-A1）K210621口内/経口注射器

公式ソース

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