Elitone Device
K-Number: K183585 · 2019-02-11
ApplicantElidah, Inc.
Decision Date2019-02-11
Product CodeQAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Elitone Device is a medical device manufactured by Elidah, Inc.. It received FDA 510(k) clearance on 2019-02-11 under approval number K183585. The device is classified under product code QAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Elitone Device?
Elitone Device is a medical device that received FDA 510(k) clearance on 2019-02-11. It is manufactured by Elidah, Inc.. The 510(k) number is K183585.
When was Elitone Device approved by the FDA?
Elitone Device received FDA 510(k) clearance on 2019-02-11, under approval number K183585.
What company makes Elitone Device?
Elitone Device is manufactured by Elidah, Inc..
What is the FDA product code for Elitone Device?
The FDA product code for Elitone Device is QAJ.
Other Devices by Elidah, Inc.
Related Devices (Code: QAJ)
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.