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FDA 510(k)

Cardiologs Holter Platform

K-Number: K250569 · 2025-08-06

ApplicantPhilips France Commercial
Decision Date2025-08-06
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cardiologs Holter Platform is a medical device manufactured by Philips France Commercial. It received FDA 510(k) clearance on 2025-08-06 under approval number K250569. 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 2025-08-06. It is manufactured by Philips France Commercial. The 510(k) number is K250569.

When was Cardiologs Holter Platform approved by the FDA?

Cardiologs Holter Platform received FDA 510(k) clearance on 2025-08-06, under approval number K250569.

What company makes Cardiologs Holter Platform?

Cardiologs Holter Platform is manufactured by Philips France Commercial.

What is the FDA product code for Cardiologs Holter Platform?

The FDA product code for Cardiologs Holter Platform is DPS.

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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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