FDA 510(k)

泰魯斯C1

K 號：K151996 · 2016-01-22

決定日期2016-01-22

產品代碼EIA

諮詢委員會DE

決定相當於

器材摘要

TAURUS C1 is the device name listed in this FDA 510(k) record. The listed applicant is Shinhung Company, Ltd.. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K151996. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TAURUS C1?

TAURUS C1 is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Shinhung Company, Ltd.. The 510(k) number is K151996.

When did TAURUS C1 receive FDA 510(k) clearance?

TAURUS C1 received FDA 510(k) clearance on 2016-01-22, under 510(k) number K151996.

Who is the listed applicant for TAURUS C1?

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

What is the FDA product code for TAURUS C1?

The FDA product code for TAURUS C1 is EIA.

其他以 Shinhung Company, Ltd. 為申請人之記錄

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