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SURESIGNS VM SERIES PATIENT MONITOR - Vm6

FDA 510(k)

Class II (US FDA 510(k))

510(k) K080495

by Philips Medical Systems

Identifiers

510(k) Number
K080495 FDA 510(k)
FDA Product Code
MHX FDA 510(k)
Models / Variants
Vm4 FDA 510(k)
Vm6 FDA 510(k)
Vm8 FDA 510(k)
Vm3 FDA 510(k)
Vs3 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)

SURESIGNS VM SERIES PATIENT MONITOR - Vm6 by Philips Medical Systems — Class II — FDA_510K — listed in FDA 510(k) — 5 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K080495 24 fields · synced Jun 19, 2026