FDA 510(k)

生命指標

K 號：K243687 · 2025-08-27

決定日期2025-08-27

產品代碼QME

諮詢委員會履歷

決定相當於

器材摘要

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 2025-08-27 under 510(k) number K243687. 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 Vital Signs?

Vital Signs is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Oxehealth Limited. The 510(k) number is K243687.

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

Vital Signs received FDA 510(k) clearance on 2025-08-27, under 510(k) number K243687.

Who is the listed applicant for 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 Vital Signs?

The FDA product code for 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 K233618Oxevision 睡眠設備 K220899Oxehealth 預防性生命徵象監測設備 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 K250078知情生命核心應用程式（IVC App）（v2.0.0.2.0.0）Mindset Medical, Inc.K240890全視野AI生命徵象PanopticAI technologies Limited

官方來源

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