FDA 510(k)

Sonicaid Team3

K 號：K241368 · 2025-02-03

決定日期2025-02-03

產品代碼HGM

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

Sonicaid Team3 is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare , Ltd.. It received FDA 510(k) clearance on 2025-02-03 under 510(k) number K241368. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sonicaid Team3?

Sonicaid Team3 is a medical device that received FDA 510(k) clearance on 2025-02-03. The listed applicant is Huntleigh Healthcare , Ltd.. The 510(k) number is K241368.

When did Sonicaid Team3 receive FDA 510(k) clearance?

Sonicaid Team3 received FDA 510(k) clearance on 2025-02-03, under 510(k) number K241368.

Who is the listed applicant for Sonicaid Team3?

The FDA 510(k) record lists Huntleigh Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonicaid Team3?

The FDA product code for Sonicaid Team3 is HGM.

其他以 Huntleigh Healthcare , 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。

K250777Sonicaid Team3 K211200傷口表達 K183574SRX手持式多普勒，DMX手持式多普勒，產科探頭，血管探頭 K152228Hydroven 12, Hydroven 12 衣物

相關器械（代碼：HGM）

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。

K254036Novii+ 電子貼片系統Datex Ohmeda, Inc.K253021ANNE 妇科Sibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882胎兒及母親監護器（F15A，F15A Air）Edan Instruments, Inc.K241009PeriCALM 模式 3.0Perigen, Inc.K233440Avalon CL 胎兒與母親 (F&M) Pod (866488)，Avalon CL 胎兒與母親 (F&M) 贴片 (989803196341)Philips Medizin Systeme Boeblingen GmbH

官方來源

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