FDA 510(k)

不規則心拍モニタ付Study Watch

K番号: K192415 · 2020-01-17

決定日2020-01-17

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

Study Watch with Irregular Pulse Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Verily Life Sciences, LLC. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K192415. 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 Study Watch with Irregular Pulse Monitor?

Study Watch with Irregular Pulse Monitor is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Verily Life Sciences, LLC. The 510(k) number is K192415.

When did Study Watch with Irregular Pulse Monitor receive FDA 510(k) clearance?

Study Watch with Irregular Pulse Monitor received FDA 510(k) clearance on 2020-01-17, under 510(k) number K192415.

Who is the listed applicant for Study Watch with Irregular Pulse Monitor?

The FDA 510(k) record lists Verily Life Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Study Watch with Irregular Pulse Monitor?

The FDA product code for Study Watch with Irregular Pulse Monitor is DXH. This falls under the Hematology category.

申請者としてVerily Life Sciences, LLCを記載するその他の記録

K242508ベリリィナミクティックレチナルカメラ K213357不規則心拍モニタ付きスタディウォッチ（ホーム）、不規則心拍モニタ付きスタディウォッチ K182456研究ウォッチ

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