Cadwell Zenith System
K-Number: K181466 · 2018-09-01
ApplicantCadwell Industries, Inc.
Decision Date2018-09-01
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Cadwell Zenith System is a medical device manufactured by Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2018-09-01 under approval number K181466. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cadwell Zenith System?
Cadwell Zenith System is a medical device that received FDA 510(k) clearance on 2018-09-01. It is manufactured by Cadwell Industries, Inc.. The 510(k) number is K181466.
When was Cadwell Zenith System approved by the FDA?
Cadwell Zenith System received FDA 510(k) clearance on 2018-09-01, under approval number K181466.
What company makes Cadwell Zenith System?
Cadwell Zenith System is manufactured by Cadwell Industries, Inc..
What is the FDA product code for Cadwell Zenith System?
The FDA product code for Cadwell Zenith System is GWQ.
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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.