FDA 510(k)

Surgify 銀河

K 號：K232684 · 2023-11-29

決定日期2023-11-29

產品代碼HBE

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Surgify Halo is the device name listed in this FDA 510(k) record. The listed applicant is Surgify Medical OY. It received FDA 510(k) clearance on 2023-11-29 under 510(k) number K232684. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Surgify Halo?

Surgify Halo is a medical device that received FDA 510(k) clearance on 2023-11-29. The listed applicant is Surgify Medical OY. The 510(k) number is K232684.

When did Surgify Halo receive FDA 510(k) clearance?

Surgify Halo received FDA 510(k) clearance on 2023-11-29, under 510(k) number K232684.

Who is the listed applicant for Surgify Halo?

The FDA 510(k) record lists Surgify Medical OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgify Halo?

The FDA product code for Surgify Halo is HBE.

其他以 Surgify Medical OY 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。

K253627Surgify Halo (54.085.SHD.U1)；Surgify Halo (54.140.SHD. U1)；Surgify Halo (54.070.NVG.U1)；Surgify Halo (54.125.NVG.U1)；Surgify Halo (54.000.SEE.U1)；Surgify Halo (40.070.NVG.U1)；Surgify Halo (40.125.NVG.U1)；Surgify Halo (40.000.SEE.U1)；Surgify Halo (30.070.NVG.U2)；Surgify Halo (30.125.NVG.U2)；Surgify Halo (30.000.SEE.U2)K251433Surgify Halo (54.085.SHD.H1)；Surgify Halo (54.140.SHD.H1)；Surgify Halo (54.070.NVG.H1)；Surgify Halo (54.125.NVG.H1)；Surgify Halo (54.000.SEE.H1)；Surgify Halo (40.070.NVG.H1)；Surgify Halo (40.125.NVG.H1)；Surgify Halo (40.000.SEE.H1)K250380Surgify Halo (54.085.SHD.H1)；Surgify Halo (54.140.SHD.H1)；Surgify Halo (54.070.NVG.H1)；Surgify Halo (54.125.NVG.H1)；Surgify Halo (54.000.SEE.H1)

相關器械（代碼：HBE）

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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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。