FDA 510(k)

SIGMA P5 / OMEGA P7 / LAMBDA P9 輕便式超音波診斷掃描儀

K 號：K160343 · 2016-04-07

申請人Beijing East Whale Imaging Technology Co., Ltd.

決定日期2016-04-07

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner is the device name listed in this FDA 510(k) record. The listed applicant is Beijing East Whale Imaging Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-04-07 under 510(k) number K160343. 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 SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner?

SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner is a medical device that received FDA 510(k) clearance on 2016-04-07. The listed applicant is Beijing East Whale Imaging Technology Co., Ltd.. The 510(k) number is K160343.

When did SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner receive FDA 510(k) clearance?

SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner received FDA 510(k) clearance on 2016-04-07, under 510(k) number K160343.

Who is the listed applicant for SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner?

The FDA 510(k) record lists Beijing East Whale Imaging Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner?

The FDA product code for SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner is IYN.

其他以 Beijing East Whale Imaging Technology Co., Ltd. 為申請人之記錄

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K163429B6 K160984多掃G臂系統

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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