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FDA 510(k)

Patient Information Center iX

K-Number: K211900 · 2022-03-04

ApplicantPhilips Medizin Systeme Böblingen GmbH
Decision Date2022-03-04
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Patient Information Center iX is a medical device manufactured by Philips Medizin Systeme Böblingen GmbH. It received FDA 510(k) clearance on 2022-03-04 under approval number K211900. 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 Patient Information Center iX?

Patient Information Center iX is a medical device that received FDA 510(k) clearance on 2022-03-04. It is manufactured by Philips Medizin Systeme Böblingen GmbH. The 510(k) number is K211900.

When was Patient Information Center iX approved by the FDA?

Patient Information Center iX received FDA 510(k) clearance on 2022-03-04, under approval number K211900.

What company makes Patient Information Center iX?

Patient Information Center iX is manufactured by Philips Medizin Systeme Böblingen GmbH.

What is the FDA product code for Patient Information Center iX?

The FDA product code for Patient Information Center iX is MHX.

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Related PubMed Literature

PMID: 41400766 Publicly Available Clinical Trial Safety Data: Review and a Call for Standardization and Improved Reporting Practices. Pharmaceutical medicine (2026)

Other Devices by Philips Medizin Systeme Böblingen GmbH

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) K241890Philips Holter Analysis System

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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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