FDA 510(k)

ARTLINE

K 號：K160448 · 2016-07-12

申請人Health Line International Corporation

決定日期2016-07-12

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

ARTLINE is the device name listed in this FDA 510(k) record. The listed applicant is Health Line International Corporation. It received FDA 510(k) clearance on 2016-07-12 under 510(k) number K160448. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARTLINE?

ARTLINE is a medical device that received FDA 510(k) clearance on 2016-07-12. The listed applicant is Health Line International Corporation. The 510(k) number is K160448.

When did ARTLINE receive FDA 510(k) clearance?

ARTLINE received FDA 510(k) clearance on 2016-07-12, under 510(k) number K160448.

Who is the listed applicant for ARTLINE?

The FDA 510(k) record lists Health Line International Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTLINE?

The FDA product code for ARTLINE is DQY.

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