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FDA 510(k)

Telemetry Monitor 5500 Release 4.0 (867232)

K-Number: K242962 · 2025-05-05

ApplicantPhilips Medizin Systeme Böblingen GmbH
Decision Date2025-05-05
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Telemetry Monitor 5500 Release 4.0 (867232) is a medical device manufactured by Philips Medizin Systeme Böblingen GmbH. It received FDA 510(k) clearance on 2025-05-05 under approval number K242962. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Telemetry Monitor 5500 Release 4.0 (867232)?

Telemetry Monitor 5500 Release 4.0 (867232) is a medical device that received FDA 510(k) clearance on 2025-05-05. It is manufactured by Philips Medizin Systeme Böblingen GmbH. The 510(k) number is K242962.

When was Telemetry Monitor 5500 Release 4.0 (867232) approved by the FDA?

Telemetry Monitor 5500 Release 4.0 (867232) received FDA 510(k) clearance on 2025-05-05, under approval number K242962.

What company makes Telemetry Monitor 5500 Release 4.0 (867232)?

Telemetry Monitor 5500 Release 4.0 (867232) is manufactured by Philips Medizin Systeme Böblingen GmbH.

What is the FDA product code for Telemetry Monitor 5500 Release 4.0 (867232)?

The FDA product code for Telemetry Monitor 5500 Release 4.0 (867232) is MHX.

Related Clinical Trials

NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED

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Related Devices (Code: MHX)

K160981Patient MonitorEdan Instruments, Inc. K153707Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800Philips Medizin Systeme Boeblingen GmbH K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems

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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