M3290a Intellivue Information Center Software, Release J.00 (for M3140 +7 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062271

Identifiers

510(k) Number: K062271 FDA 510(k)
FDA Product Code: MHX FDA 510(k)
Models / Variants: for M3140 FDA 510(k)
M3145 FDA 510(k)
M3150 FDA 510(k)
M3151 FDA 510(k)
M3154 FDA 510(k)
M3155 FDA 510(k)
M3169 FDA 510(k)
M3170 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)

M3290a Intellivue Information Center Software, Release J.00 (for M3140 +7 more) by Philips Medical Systems — Class II — FDA_510K — listed in FDA 510(k) — 8…

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	K062271	Class II	Active

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Manufacturer

Manufacturer: Philips Medical Systems

Sources (1)

FDA 510(k) K062271 24 fields · synced Jun 18, 2026