FDA 510(k)

自動バイオプシー針 BAM、半自動針 BIM

K番号: K233294 · 2024-06-18

申請者Itp Innovative Tomography Products GmbH

決定日2024-06-18

製品コードKNW

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

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM is the device name listed in this FDA 510(k) record. The listed applicant is Itp Innovative Tomography Products GmbH. It received FDA 510(k) clearance on 2024-06-18 under 510(k) number K233294. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM?

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM is a medical device that received FDA 510(k) clearance on 2024-06-18. The listed applicant is Itp Innovative Tomography Products GmbH. The 510(k) number is K233294.

When did Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM receive FDA 510(k) clearance?

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM received FDA 510(k) clearance on 2024-06-18, under 510(k) number K233294.

Who is the listed applicant for Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM?

The FDA 510(k) record lists Itp Innovative Tomography Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM?

The FDA product code for Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM is KNW.

申請者としてItp Innovative Tomography Products GmbHを記載するその他の記録

K222462半自動バイオプシー針（BIM 18/20）；半自動バイオプシー針（BIM 18.15）；半自動バイオプシー針（BIM 18/10）；半自動バイオプシー針（BIM 16/20）；半自動バイオプシー針（BIM 16/15）；半自動バイオプシー針（BIM 16/10）；半自動バイオプシー針（BIM 14/20）；半自動バイオプシー針（BIM 14/15）；半自動バイオプシー針（BIM 14/10）

公式ソース

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