免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

紅外線額頭體溫計，型號：HS-9802D

K 號：K213038 · 2022-03-10

申請人Jiaxing Shangjia Intelligence Technology Co., Ltd.
決定日期2022-03-10
產品代碼FLL
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

Infrared Forehead Thermometer, model: HS-9802D is the device name listed in this FDA 510(k) record. The listed applicant is Jiaxing Shangjia Intelligence Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K213038. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Infrared Forehead Thermometer, model: HS-9802D?

Infrared Forehead Thermometer, model: HS-9802D is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Jiaxing Shangjia Intelligence Technology Co., Ltd.. The 510(k) number is K213038.

When did Infrared Forehead Thermometer, model: HS-9802D receive FDA 510(k) clearance?

Infrared Forehead Thermometer, model: HS-9802D received FDA 510(k) clearance on 2022-03-10, under 510(k) number K213038.

Who is the listed applicant for Infrared Forehead Thermometer, model: HS-9802D?

The FDA 510(k) record lists Jiaxing Shangjia Intelligence Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Forehead Thermometer, model: HS-9802D?

The FDA product code for Infrared Forehead Thermometer, model: HS-9802D is FLL.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：FLL）

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。

K253162溫度探針（T2252-PG）；溫度探針（TCMA-AG）；溫度探針（TCMA-PG）；溫度探針（TMQ-DAG）；溫度探針（THP-DAG）Unimed Medical Supplies, Inc.K251160無菌溫度探針（型號：W0001ES、W0028ES、W0101FS-A、W0101FS-P、W0099LS、W0099FS、W0099PS）Shenzhen Med-Link Electronics Tech Co., Ltd.K250470耳溫計（EAR-E101）；耳溫計（EAR-E102）；耳溫計（EAR-E103）Shenzhen AOJ Medical Technology Co., Ltd.K243000可重用溫度探針（T1306、T2306、T3306、T4306）；一次性溫度探針（T5106、T6106）Shenzhen Medke Technology Co., Ltd.K250878YUWELL® 紅外線耳溫計（YHT100）；YUWELL® 紅外線耳溫計（YHT107）Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082紅外線體溫計Guangzhou Daxin Health Technology Co., Ltd.

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。

↑