FDA 510(k)

LifeLens 電子心電圖監護器

K 號：K203168 · 2021-07-20

決定日期2021-07-20

產品代碼DSH

諮詢委員會履歷

決定相當於

器材摘要

LifeLens Wireless ECG Monitor is the device name listed in this FDA 510(k) record. The listed applicant is LifeLens Technologies, Inc.. It received FDA 510(k) clearance on 2021-07-20 under 510(k) number K203168. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LifeLens Wireless ECG Monitor?

LifeLens Wireless ECG Monitor is a medical device that received FDA 510(k) clearance on 2021-07-20. The listed applicant is LifeLens Technologies, Inc.. The 510(k) number is K203168.

When did LifeLens Wireless ECG Monitor receive FDA 510(k) clearance?

LifeLens Wireless ECG Monitor received FDA 510(k) clearance on 2021-07-20, under 510(k) number K203168.

Who is the listed applicant for LifeLens Wireless ECG Monitor?

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

What is the FDA product code for LifeLens Wireless ECG Monitor?

The FDA product code for LifeLens Wireless ECG Monitor is DSH.

其他以 LifeLens Technologies, Inc. 為申請人之記錄

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K260157LifeLens生理監測器

相關器械（代碼：DSH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260157LifeLens生理監測器LifeLens Technologies, Inc.K252389節奏主將心電圖貼片（HM-15BB-AX，HM-15BW-AX，HM-15BW-DX）Smwmed, Inc.K253293VitaloJAK 诊所（型號 7100）Vitalograph , Ltd.K243650Zio® 監護器（DFG0001）iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

官方來源

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