FDA 510(k)

簡單感應器

K 號：K201669 · 2020-11-06

決定日期2020-11-06

產品代碼DXH

諮詢委員會履歷

決定相當於

器材摘要

SimpleSENSE is the device name listed in this FDA 510(k) record. The listed applicant is Nanowear, Inc.. It received FDA 510(k) clearance on 2020-11-06 under 510(k) number K201669. 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.

常見問題

What is the SimpleSENSE?

SimpleSENSE is a medical device that received FDA 510(k) clearance on 2020-11-06. The listed applicant is Nanowear, Inc.. The 510(k) number is K201669.

When did SimpleSENSE receive FDA 510(k) clearance?

SimpleSENSE received FDA 510(k) clearance on 2020-11-06, under 510(k) number K201669.

Who is the listed applicant for SimpleSENSE?

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

What is the FDA product code for SimpleSENSE?

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

其他以 Nanowear, Inc. 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。

K232053SimpleSense-BP, SimpleSense-BP 軟體應用程序 K212160SimpleSENSE 平台 K161431簡易心電圖

相關器械（代碼：DXH）

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。

K250233預防AI臨床SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258心輝 Aimigo 配備 12-L 心電圖合成軟體系統Heartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin醫療系統（7100-00016）Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT 心電圖 (QTERD100)QT Medical, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。