FDA 510(k)

Oxehealth 預防性生命徵象監測設備

K 號：K220899 · 2022-04-29

決定日期2022-04-29

產品代碼QME

諮詢委員會履歷

決定相當於

器材摘要

Oxehealth Vital Signs is the device name listed in this FDA 510(k) record. The listed applicant is Oxehealth Limited. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K220899. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Oxehealth Vital Signs?

Oxehealth Vital Signs is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Oxehealth Limited. The 510(k) number is K220899.

When did Oxehealth Vital Signs receive FDA 510(k) clearance?

Oxehealth Vital Signs received FDA 510(k) clearance on 2022-04-29, under 510(k) number K220899.

Who is the listed applicant for Oxehealth Vital Signs?

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

What is the FDA product code for Oxehealth Vital Signs?

The FDA product code for Oxehealth Vital Signs is QME.

其他以 Oxehealth Limited 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。

K251200生命指標 K243687生命指標 K233618Oxevision 睡眠設備 K211906生命指標

相關器械（代碼：QME）

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。

K254169智能光譜生命徵象監測器 1.0Presage Security, Inc. d/b/a Presage Technologies, Inc.K253650Anura Mobile Core SDK (M1)Nuralogix Corporation K260066全視野AI生命徵象（1.6.1-22）PanopticAI Technologies Limited K251200生命指標Oxehealth Limited K243687生命指標Oxehealth Limited K250078知情生命核心應用程式（IVC App）（v2.0.0.2.0.0）Mindset Medical, Inc.

官方來源

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