FDA 510(k)

DUS-7000 デジタルカラーアルテリアスコープシステム

K番号: K172055 · 2017-08-31

決定日2017-08-31

製品コードIYN

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

DUS-7000 Digital Color Doppler Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Instrumentations, Inc.. It received FDA 510(k) clearance on 2017-08-31 under 510(k) number K172055. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the DUS-7000 Digital Color Doppler Ultrasound System?

DUS-7000 Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-08-31. The listed applicant is Advanced Instrumentations, Inc.. The 510(k) number is K172055.

When did DUS-7000 Digital Color Doppler Ultrasound System receive FDA 510(k) clearance?

DUS-7000 Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2017-08-31, under 510(k) number K172055.

Who is the listed applicant for DUS-7000 Digital Color Doppler Ultrasound System?

The FDA 510(k) record lists Advanced Instrumentations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUS-7000 Digital Color Doppler Ultrasound System?

The FDA product code for DUS-7000 Digital Color Doppler Ultrasound System is IYN.

申請者としてAdvanced Instrumentations, Inc.を記載するその他の記録

K172931DUS-6000 デジタル超音波診断画像システム

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。