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Joimax Intracs System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K192663

by Joimax GmbH

Identifiers

510(k) Number
K192663 FDA 510(k)
FDA Product Code
OLO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Joimax Intracs System by Joimax GmbH — 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
Joimax GmbH

Sources (1)

  • FDA 510(k) K192663 24 fields · synced Jun 18, 2026