FDA 510(k)

飛鳳

K 號：K212291 · 2021-09-14

決定日期2021-09-14

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

PHOENIX is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2021-09-14 under 510(k) number K212291. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PHOENIX?

PHOENIX is a medical device that received FDA 510(k) clearance on 2021-09-14. The listed applicant is Sedecal., Sa.. The 510(k) number is K212291.

When did PHOENIX receive FDA 510(k) clearance?

PHOENIX received FDA 510(k) clearance on 2021-09-14, under 510(k) number K212291.

Who is the listed applicant for PHOENIX?

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

What is the FDA product code for PHOENIX?

The FDA product code for PHOENIX is IZL.

其他以 Sedecal., Sa. 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。

K232185SM-IV K222951SM-V K221803PHOENIX/AeroDR TX m01 及 PHOENIX/mKDR Xpress。K203537Proteus XR/f，型號ST和ET，多輻射和多輻射NET射線系統 K202293影像系統挑戰X K192936Soltus 500

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相關器械（代碼：IZL）

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。

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058攜帶式DR影像系統Shantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO移動X光系統（型號：RAYMO）DRGEM Corporation K253185Lux HD 檢測器，DRX-LC 檢測器，DRX-Revolution 移動 X 光系統Carestream Health K253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

官方來源

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