eMotus Respiratory Motion Management System
K-Number: K243900 · 2025-06-27
ApplicantEmpnia, Inc.
Decision Date2025-06-27
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
eMotus Respiratory Motion Management System is a medical device manufactured by Empnia, Inc.. It received FDA 510(k) clearance on 2025-06-27 under approval number K243900. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the eMotus Respiratory Motion Management System?
eMotus Respiratory Motion Management System is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by Empnia, Inc.. The 510(k) number is K243900.
When was eMotus Respiratory Motion Management System approved by the FDA?
eMotus Respiratory Motion Management System received FDA 510(k) clearance on 2025-06-27, under approval number K243900.
What company makes eMotus Respiratory Motion Management System?
eMotus Respiratory Motion Management System is manufactured by Empnia, Inc..
What is the FDA product code for eMotus Respiratory Motion Management System?
The FDA product code for eMotus Respiratory Motion Management System is LHN.
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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.