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510(k) K243727

Re:Balans by Mode Sensors AS — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2025
Date Received
December 3, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Plethysmograph, Impedance
Device Class
Class II
Regulation Number
870.2770
Review Panel
CV
Submission Type

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