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Reusable Silicone Cover CPRmeter 2

FDA 510(k)

Class II (US FDA 510(k))

510(k) K183348

by Laerdal Medical AS

Identifiers

510(k) Number
K183348 FDA 510(k)
FDA Product Code
LIX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5210 FDA 510(k)
Regulation Number
870.5210 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Reusable Silicone Cover CPRmeter 2 by Laerdal Medical AS — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Laerdal Medical AS

Sources (1)

  • FDA 510(k) K183348 24 fields · synced Jun 19, 2026