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FDA 510(k)

Re:Balans

K-Number: K243727 · 2025-10-16

ApplicantMode Sensors AS
Decision Date2025-10-16
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Re:Balans is a medical device manufactured by Mode Sensors AS. It received FDA 510(k) clearance on 2025-10-16 under approval number K243727. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Re:Balans?

Re:Balans is a medical device that received FDA 510(k) clearance on 2025-10-16. It is manufactured by Mode Sensors AS. The 510(k) number is K243727.

When was Re:Balans approved by the FDA?

Re:Balans received FDA 510(k) clearance on 2025-10-16, under approval number K243727.

What company makes Re:Balans?

Re:Balans is manufactured by Mode Sensors AS.

What is the FDA product code for Re:Balans?

The FDA product code for Re:Balans is DSB.

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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.

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