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FDA 510(k)

CSF-3

K-Number: K221260 · 2023-01-06

ApplicantCardiacsense
Decision Date2023-01-06
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CSF-3 is a medical device manufactured by Cardiacsense. It received FDA 510(k) clearance on 2023-01-06 under approval number K221260. 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-3?

CSF-3 is a medical device that received FDA 510(k) clearance on 2023-01-06. It is manufactured by Cardiacsense. The 510(k) number is K221260.

When was CSF-3 approved by the FDA?

CSF-3 received FDA 510(k) clearance on 2023-01-06, under approval number K221260.

What company makes CSF-3?

CSF-3 is manufactured by Cardiacsense.

What is the FDA product code for CSF-3?

The FDA product code for CSF-3 is DPS.

Other Devices by Cardiacsense

K232445CSF-4 (CSF-4)

Related Devices (Code: DPS)

K160746CARDIOLINE touchECGCardioline S.P.A K160840ECG100+, ECG200+Cardioline S.P.A K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc. K161302PC ECGEdan Instruments, Inc. K152863Portable ECG MonitorContec Medical Systems Co.,Ltd K152043Diagnostic Station DS20Schiller AG

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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