FDA 510(k)

eXciteOSA 無遙控器版本（3000）；eXciteOSA 內建遙控器版本（6000）

K 號：K240328 · 2024-05-16

決定日期2024-05-16

產品代碼QNO

諮詢委員會DE

決定相當於

器材摘要

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) is the device name listed in this FDA 510(k) record. The listed applicant is Signifier Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K240328. The device is classified under product code QNO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)?

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Signifier Medical Technologies, Ltd.. The 510(k) number is K240328.

When did eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) receive FDA 510(k) clearance?

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) received FDA 510(k) clearance on 2024-05-16, under 510(k) number K240328.

Who is the listed applicant for eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)?

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

What is the FDA product code for eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)?

The FDA product code for eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) is QNO.

其他以 Signifier Medical Technologies, 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。

K223446eXciteOSA 無遙控功能（3000）；eXciteOSA 內建遙控功能（6000）

相關器械（代碼：QNO）

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。

K223446eXciteOSA 無遙控功能（3000）；eXciteOSA 內建遙控功能（6000）Signifier Medical Technologies, Ltd.

官方來源

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