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UGFT3 - Ugft3

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131155

by Medisim, Ltd.

Identifiers

510(k) Number: K131155 FDA 510(k)
FDA Product Code: FLL FDA 510(k)
Models / Variants: Ugft3 FDA 510(k)
Fht7 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 880.2910 FDA 510(k)
Regulation Number: 880.2910 FDA 510(k)
Advisory Committee: General Hospital FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

UGFT3 - Ugft3 by Medisim, Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 2 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer: Medisim, Ltd.

Sources (1)

FDA 510(k) K131155 24 fields · synced Jun 18, 2026