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FDA 510(k)

Philips Holter Analysis System

K-Number: K241890 · 2025-03-21

ApplicantPhilips Medizin Systeme Böblingen GmbH
Decision Date2025-03-21
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Philips Holter Analysis System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Böblingen GmbH. It received FDA 510(k) clearance on 2025-03-21 under 510(k) number K241890. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Philips Holter Analysis System?

Philips Holter Analysis System is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Philips Medizin Systeme Böblingen GmbH. The 510(k) number is K241890.

When did Philips Holter Analysis System receive FDA 510(k) clearance?

Philips Holter Analysis System received FDA 510(k) clearance on 2025-03-21, under 510(k) number K241890.

Who is the listed applicant for Philips Holter Analysis System?

The FDA 510(k) record lists Philips Medizin Systeme Böblingen GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips Holter Analysis System?

The FDA product code for Philips Holter Analysis System is MLO.

Other records listing Philips Medizin Systeme Böblingen GmbH as applicant

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Related Devices (Code: MLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240794Frontier X PlusFourth Frontier Technologies Pvt, Ltd.K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.K193177CER-SCardiocalmK182030Faros MobileBittium Biosignals , Ltd.

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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