FDA 510(k)

SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0

Número K: K163339 · 2017-08-17

Data da decisão2017-08-17

Código do produtoDPT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Spectralmd, Inc.. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K163339. The device is classified under product code DPT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0?

SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Spectralmd, Inc.. The 510(k) number is K163339.

When did SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 receive FDA 510(k) clearance?

SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 received FDA 510(k) clearance on 2017-08-17, under 510(k) number K163339.

Who is the listed applicant for SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0?

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

What is the FDA product code for SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0?

The FDA product code for SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 is DPT.

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