FDA 510(k)

ReadeR，VieweR，QuickScan PSP

K 號：K160386 · 2016-03-10

決定日期2016-03-10

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

ReadeR, VieweR, QuickScan PSP is the device name listed in this FDA 510(k) record. The listed applicant is Trident S.R.L. It received FDA 510(k) clearance on 2016-03-10 under 510(k) number K160386. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ReadeR, VieweR, QuickScan PSP?

ReadeR, VieweR, QuickScan PSP is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Trident S.R.L. The 510(k) number is K160386.

When did ReadeR, VieweR, QuickScan PSP receive FDA 510(k) clearance?

ReadeR, VieweR, QuickScan PSP received FDA 510(k) clearance on 2016-03-10, under 510(k) number K160386.

Who is the listed applicant for ReadeR, VieweR, QuickScan PSP?

The FDA 510(k) record lists Trident S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ReadeR, VieweR, QuickScan PSP?

The FDA product code for ReadeR, VieweR, QuickScan PSP is MUH.

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