FDA 510(k)

LIGHTMED 超聲系統

K 號：K183173 · 2019-07-01

決定日期2019-07-01

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

LIGHTMED Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Lightmed USA, Inc.. It received FDA 510(k) clearance on 2019-07-01 under 510(k) number K183173. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LIGHTMED Ultrasound System?

LIGHTMED Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-07-01. The listed applicant is Lightmed USA, Inc.. The 510(k) number is K183173.

When did LIGHTMED Ultrasound System receive FDA 510(k) clearance?

LIGHTMED Ultrasound System received FDA 510(k) clearance on 2019-07-01, under 510(k) number K183173.

Who is the listed applicant for LIGHTMED Ultrasound System?

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

What is the FDA product code for LIGHTMED Ultrasound System?

The FDA product code for LIGHTMED Ultrasound System is IYO.

其他以 Lightmed USA, Inc. 為申請人之記錄

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相關器械（代碼：IYO）

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。

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官方來源

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