FDA 510(k)

CareEventおよびCareEventモバイルアプリケーションアクセサリーを含む

K番号: K161164 · 2016-06-24

決定日2016-06-24

製品コードMSX

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

CareEvent inclusive of the CareEvent Mobile Application accessory is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K161164. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the CareEvent inclusive of the CareEvent Mobile Application accessory?

CareEvent inclusive of the CareEvent Mobile Application accessory is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Philips Medical Systems. The 510(k) number is K161164.

When did CareEvent inclusive of the CareEvent Mobile Application accessory receive FDA 510(k) clearance?

CareEvent inclusive of the CareEvent Mobile Application accessory received FDA 510(k) clearance on 2016-06-24, under 510(k) number K161164.

Who is the listed applicant for CareEvent inclusive of the CareEvent Mobile Application accessory?

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

What is the FDA product code for CareEvent inclusive of the CareEvent Mobile Application accessory?

The FDA product code for CareEvent inclusive of the CareEvent Mobile Application accessory is MSX.

申請者としてPhilips Medical Systemsを記載するその他の記録

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