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FDA 510(k)

HeartKey® Rhythm

K-Number: K233755 · 2024-08-16

ApplicantB-Secur Limited
Decision Date2024-08-16
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HeartKey® Rhythm is a medical device manufactured by B-Secur Limited. It received FDA 510(k) clearance on 2024-08-16 under approval number K233755. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HeartKey® Rhythm?

HeartKey® Rhythm is a medical device that received FDA 510(k) clearance on 2024-08-16. It is manufactured by B-Secur Limited. The 510(k) number is K233755.

When was HeartKey® Rhythm approved by the FDA?

HeartKey® Rhythm received FDA 510(k) clearance on 2024-08-16, under approval number K233755.

What company makes HeartKey® Rhythm?

HeartKey® Rhythm is manufactured by B-Secur Limited.

What is the FDA product code for HeartKey® Rhythm?

The FDA product code for HeartKey® Rhythm is DQK.

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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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