FDA 510(k)

場地適用

K 號：K234106 · 2024-06-10

申請人GE Medical Systems Ultrasound and Primary Care Diagnostics

決定日期2024-06-10

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Venue Fit is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2024-06-10 under 510(k) number K234106. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Venue Fit?

Venue Fit is a medical device that received FDA 510(k) clearance on 2024-06-10. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K234106.

When did Venue Fit receive FDA 510(k) clearance?

Venue Fit received FDA 510(k) clearance on 2024-06-10, under 510(k) number K234106.

Who is the listed applicant for Venue Fit?

FDA 510(k) 記錄將GE醫療系統超聲波和基礎醫療診斷列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Venue Fit?

The FDA product code for Venue Fit is IYN.

其他以 GE Medical Systems Ultrasound and Primary Care Diagnostics 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。

K261623EchoPAC 軟體僅 / EchoPAC 插件（v211）K261313Vivid 探索者/Vivid 高級/Vivid 焦點 K261835LOGIQ Focus K260398LOGIQ e 医療設備規範文本 LOGIQ e 医療設備之規範性文件，請參考以下內容：公司名稱：[公司名稱] 產品名稱：LOGIQ e 美國食品藥品管理局（FDA）許可文號：[許可文號] 510(k)許可：[510(k)許可文號] PMA許可：[PMA許可文號] 臨床試驗登錄號（NCT）：[NCT號碼] PubMed ID（PMID）：[PMID號碼] 識別碼：[識別碼] 相關網址：[URL] 請遵守以下政策：medical-regulatory-v1 K260673LOGIQ Vita；LOGIQ Vita Pro；LOGIQ Vita Express；LOGIQ Vita Plus；LOGIQ Vita Power；LOGIQ S20；LOGIQ S20 Pro；LOGIQ S20 Express；LOGIQ S20 Plus；LOGIQ S20 Power K253370LOGIQ Totus

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相關器械（代碼：IYN）

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。

官方來源

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