FDA 510(k)

VisCalor

K号: K201307 · 2020-07-08

决定日期2020-07-08

产品代码EBF

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决定实质等同

器械摘要

VisCalor is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2020-07-08 under 510(k) number K201307. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VisCalor?

VisCalor is a medical device that received FDA 510(k) clearance on 2020-07-08. The listed applicant is Voco GmbH. The 510(k) number is K201307.

When did VisCalor receive FDA 510(k) clearance?

VisCalor received FDA 510(k) clearance on 2020-07-08, under 510(k) number K201307.

Who is the listed applicant for VisCalor?

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

What is the FDA product code for VisCalor?

The FDA product code for VisCalor is EBF.

列明Voco GmbH为申报人的其他记录

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