Intellivue Patient Monitors With Release C.02 (Mp20 +7 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K052801

by Philips Medizin Systeme Boeblingen GmbH

Identifiers

510(k) Number: K052801 FDA 510(k)
FDA Product Code: MHX FDA 510(k)
Models / Variants: Mp20 FDA 510(k)
Mp30 FDA 510(k)
Mp40 FDA 510(k)
Mp50 FDA 510(k)
Mp60 FDA 510(k)
Mp70 FDA 510(k)
Mp80 FDA 510(k)
Mp90 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 870.1025 FDA 510(k)
Regulation Number: 870.1025 FDA 510(k)
Advisory Committee: Cardiovascular FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Intellivue Patient Monitors With Release C.02 (Mp20 +7 more) by Philips Medizin Systeme Boeblingen GmbH — Class II — FDA_510K — listed in FDA 510(k) — 8 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K052801	Class II	Active

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Manufacturer

Manufacturer: Philips Medizin Systeme Boeblingen GmbH

Sources (1)

FDA 510(k) K052801 24 fields · synced Jun 18, 2026