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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K243727
Device Name Re:Balans
Applicant
Mode Sensors AS
Professor Brochs Gate 2
Trondheim,  NO 7030
Applicant Contact Magnus Nordahl
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.2770
Classification Product Code
DSB  
Date Received12/03/2024
Decision Date 10/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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