FDA 510(k)

TheraCal DC

K 號：K180344 · 2018-04-05

決定日期2018-04-05

產品代碼EJK

諮詢委員會DE

決定相當於

器材摘要

TheraCal DC is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K180344. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TheraCal DC?

TheraCal DC is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Bisco, Inc.. The 510(k) number is K180344.

When did TheraCal DC receive FDA 510(k) clearance?

TheraCal DC received FDA 510(k) clearance on 2018-04-05, under 510(k) number K180344.

Who is the listed applicant for TheraCal DC?

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

What is the FDA product code for TheraCal DC?

The FDA product code for TheraCal DC is EJK.

其他以 Bisco, Inc. 為申請人之記錄

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相關器械（代碼：EJK）

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