ApneaTrak
K-Number: K192624 · 2020-02-20
ApplicantCadwell Industries, Inc.
Decision Date2020-02-20
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ApneaTrak is a medical device manufactured by Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2020-02-20 under approval number K192624. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ApneaTrak?
ApneaTrak is a medical device that received FDA 510(k) clearance on 2020-02-20. It is manufactured by Cadwell Industries, Inc.. The 510(k) number is K192624.
When was ApneaTrak approved by the FDA?
ApneaTrak received FDA 510(k) clearance on 2020-02-20, under approval number K192624.
What company makes ApneaTrak?
ApneaTrak is manufactured by Cadwell Industries, Inc..
What is the FDA product code for ApneaTrak?
The FDA product code for ApneaTrak is OLV.
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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.