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FDA 510(k)

SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0

K-Number: K163339 · 2017-08-17

ApplicantSpectralmd, Inc.
Decision Date2017-08-17
Product CodeDPT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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