Cadwell Apollo System
K-Number: K201819 · 2020-09-29
ApplicantCadwell Industries, Inc.
Decision Date2020-09-29
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Cadwell Apollo System is a medical device manufactured by Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2020-09-29 under approval number K201819. 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 Apollo System?
Cadwell Apollo System is a medical device that received FDA 510(k) clearance on 2020-09-29. It is manufactured by Cadwell Industries, Inc.. The 510(k) number is K201819.
When was Cadwell Apollo System approved by the FDA?
Cadwell Apollo System received FDA 510(k) clearance on 2020-09-29, under approval number K201819.
What company makes Cadwell Apollo System?
Cadwell Apollo System is manufactured by Cadwell Industries, Inc..
What is the FDA product code for Cadwell Apollo System?
The FDA product code for Cadwell Apollo 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.