FDA 510(k)

LOGIQ 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

K 號：K232186 · 2023-11-03

申請人Ge Medical Systems Ultrasound and Primary Care Diagnostic,

決定日期2023-11-03

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

LOGIQ e is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnostic,. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K232186. 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 LOGIQ e?

LOGIQ e is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnostic,. The 510(k) number is K232186.

When did LOGIQ e receive FDA 510(k) clearance?

LOGIQ e received FDA 510(k) clearance on 2023-11-03, under 510(k) number K232186.

Who is the listed applicant for LOGIQ e?

The FDA 510(k) record lists Ge Medical Systems Ultrasound and Primary Care Diagnostic, as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOGIQ e?

The FDA product code for LOGIQ e is IYN.

其他以 Ge Medical Systems Ultrasound and Primary Care Diagnostic, 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。

K231989LOGIQ E10s, LOGIQ Fortis

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

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。

器材摘要

常見問題

相關臨床試驗

其他以 Ge Medical Systems Ultrasound and Primary Care Diagnostic, 為申請人之記錄

相關器械（代碼：IYN）

官方來源