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Infuset Flow Control Extension Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K140133

by EMED Technologies Corporation

Identifiers

510(k) Number
K140133 FDA 510(k)
FDA Product Code
FPA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5440 FDA 510(k)
Regulation Number
880.5440 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Infuset Flow Control Extension Set by EMED Technologies Corporation — 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

Sources (1)

  • FDA 510(k) K140133 24 fields · synced Jun 19, 2026