SpectraWAVE Imaging System
K-Number: K221257 · 2023-02-28
ApplicantSpectrawave, Inc.
Decision Date2023-02-28
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SpectraWAVE Imaging System is a medical device manufactured by Spectrawave, Inc.. It received FDA 510(k) clearance on 2023-02-28 under approval number K221257. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SpectraWAVE Imaging System?
SpectraWAVE Imaging System is a medical device that received FDA 510(k) clearance on 2023-02-28. It is manufactured by Spectrawave, Inc.. The 510(k) number is K221257.
When was SpectraWAVE Imaging System approved by the FDA?
SpectraWAVE Imaging System received FDA 510(k) clearance on 2023-02-28, under approval number K221257.
What company makes SpectraWAVE Imaging System?
SpectraWAVE Imaging System is manufactured by Spectrawave, Inc..
What is the FDA product code for SpectraWAVE Imaging System?
The FDA product code for SpectraWAVE Imaging System is NQQ.
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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.