FDA 510(k)

CompuFlo脊椎麻酔システムコンピュータ制御式

K番号: K161883 · 2017-06-09

決定日2017-06-09

製品コードFMF

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

CompuFlo Epidural Computer Controlled Anesthesia System is the device name listed in this FDA 510(k) record. The listed applicant is Milestone Scientific, Inc.. It received FDA 510(k) clearance on 2017-06-09 under 510(k) number K161883. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the CompuFlo Epidural Computer Controlled Anesthesia System?

CompuFlo Epidural Computer Controlled Anesthesia System is a medical device that received FDA 510(k) clearance on 2017-06-09. The listed applicant is Milestone Scientific, Inc.. The 510(k) number is K161883.

When did CompuFlo Epidural Computer Controlled Anesthesia System receive FDA 510(k) clearance?

CompuFlo Epidural Computer Controlled Anesthesia System received FDA 510(k) clearance on 2017-06-09, under 510(k) number K161883.

Who is the listed applicant for CompuFlo Epidural Computer Controlled Anesthesia System?

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

What is the FDA product code for CompuFlo Epidural Computer Controlled Anesthesia System?

The FDA product code for CompuFlo Epidural Computer Controlled Anesthesia System is FMF.

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

K221702CompuFlo脊椎麻酔システムコンピュータ制御式

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