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FDA 510(k)

IntelliVue Patient monitors MX400, MX450, MX500, MX550

K-Number: K251146 · 2025-10-17

Decision Date2025-10-17
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IntelliVue Patient monitors MX400, MX450, MX500, MX550 is a medical device manufactured by Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2025-10-17 under approval number K251146. 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 IntelliVue Patient monitors MX400, MX450, MX500, MX550?

IntelliVue Patient monitors MX400, MX450, MX500, MX550 is a medical device that received FDA 510(k) clearance on 2025-10-17. It is manufactured by Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K251146.

When was IntelliVue Patient monitors MX400, MX450, MX500, MX550 approved by the FDA?

IntelliVue Patient monitors MX400, MX450, MX500, MX550 received FDA 510(k) clearance on 2025-10-17, under approval number K251146.

What company makes IntelliVue Patient monitors MX400, MX450, MX500, MX550?

IntelliVue Patient monitors MX400, MX450, MX500, MX550 is manufactured by Philips Medizin Systeme Boeblingen GmbH.

What is the FDA product code for IntelliVue Patient monitors MX400, MX450, MX500, MX550?

The FDA product code for IntelliVue Patient monitors MX400, MX450, MX500, MX550 is MHX.

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Official Source

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