FDA 510(k)

紅外線體溫計，型號編號 CK-T1501，CK-T1502，CK-T1503

K 號：K193253 · 2020-06-17

申請人Shenzhen Changkun Technology Co., Ltd.

決定日期2020-06-17

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 Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-06-17 under 510(k) number K193253. 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 Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503?

Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 is a medical device that received FDA 510(k) clearance on 2020-06-17. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. The 510(k) number is K193253.

When did Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 receive FDA 510(k) clearance?

Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 received FDA 510(k) clearance on 2020-06-17, under 510(k) number K193253.

Who is the listed applicant for Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503?

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

What is the FDA product code for Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503?

The FDA product code for Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 is FLL.

其他以 Shenzhen Changkun Technology Co., Ltd. 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。

K250070電動乳泵（MY-375、MY-376、MY-378、MY-379、MY-380、V3）K252552骨盆底復健治療設備（PD2301/PD2302/PD2303）K231595電動母乳抽乳器 K221798手指血氧計，型號：X1906P K193386手環式電子血壓計 K193387手臂電子血压计

查看所有 7 項裝置 →

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。