Cadwell Guardian
K-Number: K230415 · 2023-08-17
ApplicantCadwell Industries, Inc.
Decision Date2023-08-17
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Cadwell Guardian is a medical device manufactured by Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2023-08-17 under approval number K230415. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cadwell Guardian?
Cadwell Guardian is a medical device that received FDA 510(k) clearance on 2023-08-17. It is manufactured by Cadwell Industries, Inc.. The 510(k) number is K230415.
When was Cadwell Guardian approved by the FDA?
Cadwell Guardian received FDA 510(k) clearance on 2023-08-17, under approval number K230415.
What company makes Cadwell Guardian?
Cadwell Guardian is manufactured by Cadwell Industries, Inc..
What is the FDA product code for Cadwell Guardian?
The FDA product code for Cadwell Guardian is GWF.
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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.