FDA 510(k)

プリズマ

K番号: K170181 · 2017-09-01

決定日2017-09-01

製品コードDXH

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- **政策：medical-regulatory-v1** --- [ここに原文が記載されています] --- **会社名/製品名**：[ここに会社名または製品名が記載されています] **FDA**：食品医薬品局 **510(k)**：510(k)届出 **PMA**：プレマーケティング評価届出 **NCT**：臨床試験登録番号 **PMID**：PubMed ID **識別子**：[ここに識別子が記載されています] **URL**：[ここにURLが記載されています]

決定大幅同等

医療機器の概要

Prizma is the device name listed in this FDA 510(k) record. The listed applicant is G-Medical Innovations , Ltd.. It received FDA 510(k) clearance on 2017-09-01 under 510(k) number K170181. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

よくある質問

What is the Prizma?

Prizma is a medical device that received FDA 510(k) clearance on 2017-09-01. The listed applicant is G-Medical Innovations , Ltd.. The 510(k) number is K170181.

When did Prizma receive FDA 510(k) clearance?

Prizma received FDA 510(k) clearance on 2017-09-01, under 510(k) number K170181.

Who is the listed applicant for Prizma?

The FDA 510(k) record lists G-Medical Innovations , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prizma?

The FDA product code for Prizma is DXH. This falls under the Hematology category.

申請者としてG-Medical Innovations , Ltd.を記載するその他の記録

K173589プリズマ

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