FDA 510(k)

可重用溫度探針，一次性溫度探針

K 號：K223807 · 2023-08-25

申請人Shenzhen Sino-K Medical Technology Co.,Ltd

決定日期2023-08-25

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

Reusable Temperature Probe, Disposable Temperature Probe is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Sino-K Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K223807. 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 Reusable Temperature Probe, Disposable Temperature Probe?

Reusable Temperature Probe, Disposable Temperature Probe is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Shenzhen Sino-K Medical Technology Co.,Ltd. The 510(k) number is K223807.

When did Reusable Temperature Probe, Disposable Temperature Probe receive FDA 510(k) clearance?

Reusable Temperature Probe, Disposable Temperature Probe received FDA 510(k) clearance on 2023-08-25, under 510(k) number K223807.

Who is the listed applicant for Reusable Temperature Probe, Disposable Temperature Probe?

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

What is the FDA product code for Reusable Temperature Probe, Disposable Temperature Probe?

The FDA product code for Reusable Temperature Probe, Disposable Temperature Probe is FLL.

其他以 Shenzhen Sino-K Medical 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。

K231961NIBP 製品名稱 K192608一次性SpO2感測器

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

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