FDA 510(k)

Withings Scan Monitor 2.0

K 號：K230812 · 2023-08-23

決定日期2023-08-23

產品代碼DPS

諮詢委員會履歷

決定相當於

器材摘要

Withings Scan Monitor 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Withings. It received FDA 510(k) clearance on 2023-08-23 under 510(k) number K230812. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Withings Scan Monitor 2.0?

Withings Scan Monitor 2.0 is a medical device that received FDA 510(k) clearance on 2023-08-23. The listed applicant is Withings. The 510(k) number is K230812.

When did Withings Scan Monitor 2.0 receive FDA 510(k) clearance?

Withings Scan Monitor 2.0 received FDA 510(k) clearance on 2023-08-23, under 510(k) number K230812.

Who is the listed applicant for Withings Scan Monitor 2.0?

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

What is the FDA product code for Withings Scan Monitor 2.0?

The FDA product code for Withings Scan Monitor 2.0 is DPS.

其他以 Withings 為申請人之記錄

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。

K252474Withings BeamO (SCT02)K240795Withings 心電圖應用程式 K231667Withings 睡眠藥物 K160544Withings Thermo（型號SCT01）

相關器械（代碼：DPS）

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。

K254255S-Patch 心臟AIWellysis Corp.K252463SE-1202系列心電圖儀（型號：SE-1202，SE-1202E）Edan Instruments, Inc.K251670MAC 7 靜息心電圖分析系統Ge Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)Withings K250569Cardiologs 霍爾特平台Philips France Commercial

官方來源

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