Philips Holter Analysis System
K-Number: K241890 · 2025-03-21
Decision Date2025-03-21
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Philips Holter Analysis System is a medical device manufactured by Philips Medizin Systeme Böblingen GmbH. It received FDA 510(k) clearance on 2025-03-21 under approval 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. It is manufactured by Philips Medizin Systeme Böblingen GmbH. The 510(k) number is K241890.
When was Philips Holter Analysis System approved by the FDA?
Philips Holter Analysis System received FDA 510(k) clearance on 2025-03-21, under approval number K241890.
What company makes Philips Holter Analysis System?
Philips Holter Analysis System is manufactured by Philips Medizin Systeme Böblingen GmbH.
What is the FDA product code for Philips Holter Analysis System?
The FDA product code for Philips Holter Analysis System is MLO.
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Other Devices by Philips Medizin Systeme Böblingen GmbH
K211900Patient Information Center iX
K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)
K241556Cardiac Workstation (5000); Cardiac Workstation (7000)
K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )
K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
K242962Telemetry Monitor 5500 Release 4.0 (867232)
Related Devices (Code: MLO)
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.