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FDA 510(k)

Cardiologs Holter Platform

K-Number: K212112 · 2021-11-18

ApplicantCardiologs Technologies
Decision Date2021-11-18
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cardiologs Holter Platform is a medical device manufactured by Cardiologs Technologies. It received FDA 510(k) clearance on 2021-11-18 under approval number K212112. 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 Cardiologs Holter Platform?

Cardiologs Holter Platform is a medical device that received FDA 510(k) clearance on 2021-11-18. It is manufactured by Cardiologs Technologies. The 510(k) number is K212112.

When was Cardiologs Holter Platform approved by the FDA?

Cardiologs Holter Platform received FDA 510(k) clearance on 2021-11-18, under approval number K212112.

What company makes Cardiologs Holter Platform?

Cardiologs Holter Platform is manufactured by Cardiologs Technologies.

What is the FDA product code for Cardiologs Holter Platform?

The FDA product code for Cardiologs Holter Platform is DPS.

Other Devices by Cardiologs Technologies

K170568CardioLogs ECG Analysis Platform

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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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