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 a medical device manufactured by Spectralmd, Inc.. It received FDA 510(k) clearance on 2017-08-17 under approval 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. It is manufactured by Spectralmd, Inc.. The 510(k) number is K163339.
When was SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 approved by the FDA?
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 received FDA 510(k) clearance on 2017-08-17, under approval number K163339.
What company makes SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0?
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 is manufactured by Spectralmd, Inc..
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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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.