FDA 510(k)

AK 98透析機、U9000超濾器、C705拡張室アクセサリー

K番号: K201809 · 2021-03-10

決定日2021-03-10

製品コードKDI

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

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corportation. It received FDA 510(k) clearance on 2021-03-10 under 510(k) number K201809. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory is a medical device that received FDA 510(k) clearance on 2021-03-10. The listed applicant is Baxter Healthcare Corportation. The 510(k) number is K201809.

When did AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory receive FDA 510(k) clearance?

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory received FDA 510(k) clearance on 2021-03-10, under 510(k) number K201809.

Who is the listed applicant for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

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

What is the FDA product code for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

The FDA product code for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory is KDI.

申請者としてBaxter Healthcare Corportationを記載するその他の記録

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