ApneaRX Pro
K-Number: K223901 · 2023-09-01
ApplicantApnea Sciences Coporation
Decision Date2023-09-01
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ApneaRX Pro is a medical device manufactured by Apnea Sciences Coporation. It received FDA 510(k) clearance on 2023-09-01 under approval number K223901. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ApneaRX Pro?
ApneaRX Pro is a medical device that received FDA 510(k) clearance on 2023-09-01. It is manufactured by Apnea Sciences Coporation. The 510(k) number is K223901.
When was ApneaRX Pro approved by the FDA?
ApneaRX Pro received FDA 510(k) clearance on 2023-09-01, under approval number K223901.
What company makes ApneaRX Pro?
ApneaRX Pro is manufactured by Apnea Sciences Coporation.
What is the FDA product code for ApneaRX Pro?
The FDA product code for ApneaRX Pro is LRK.
Related Devices (Code: LRK)
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.