FDA 510(k)

J型骨髄生検針、T型骨髄生検針、ツイーザー骨髄生検針

K番号: K190177 · 2019-06-12

決定日2019-06-12

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

J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, is the device name listed in this FDA 510(k) record. The listed applicant is Ranfac Corporation. It received FDA 510(k) clearance on 2019-06-12 under 510(k) number K190177. 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 J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,?

J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, is a medical device that received FDA 510(k) clearance on 2019-06-12. The listed applicant is Ranfac Corporation. The 510(k) number is K190177.

When did J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, receive FDA 510(k) clearance?

J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, received FDA 510(k) clearance on 2019-06-12, under 510(k) number K190177.

Who is the listed applicant for J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,?

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

What is the FDA product code for J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,?

The FDA product code for J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, is KNW.

申請者としてRanfac Corporationを記載するその他の記録

K223612ランファック横断アクセス骨髄吸引針（CRVS-BMA-LA）K202287ラン・フレックス・B 骨髄吸引針 K183146ランファックカルテラバイオプシー針

公式ソース

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