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FDA 510(k)

CSF-4 (CSF-4)

K-Number: K232445 · 2024-05-02

ApplicantCardiacsense
Decision Date2024-05-02
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CSF-4 (CSF-4) is a medical device manufactured by Cardiacsense. It received FDA 510(k) clearance on 2024-05-02 under approval number K232445. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CSF-4 (CSF-4)?

CSF-4 (CSF-4) is a medical device that received FDA 510(k) clearance on 2024-05-02. It is manufactured by Cardiacsense. The 510(k) number is K232445.

When was CSF-4 (CSF-4) approved by the FDA?

CSF-4 (CSF-4) received FDA 510(k) clearance on 2024-05-02, under approval number K232445.

What company makes CSF-4 (CSF-4)?

CSF-4 (CSF-4) is manufactured by Cardiacsense.

What is the FDA product code for CSF-4 (CSF-4)?

The FDA product code for CSF-4 (CSF-4) is DPS.

Other Devices by Cardiacsense

K221260CSF-3

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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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