eMotus Respiratory Motion Management System— 510(k) K243900

Substantially Equivalent

Empnia, Inc.

FDA 510(k) clearance K243900 for eMotus Respiratory Motion Management System, Substantially Equivalent on 2025-06-27. Applicant: Empnia, Inc.. Device class: 2.

Clearance details

Applicant
Empnia, Inc.
Product code
Code LHN
Device class
Class 2
Regulation
21 CFR 892.5050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Edina, MN, US
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