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Disposable Infusion Pump Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K993972

by Biomet, Inc.

Identifiers

510(k) Number
K993972 FDA 510(k)
FDA Product Code
MEB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5725 FDA 510(k)
Regulation Number
880.5725 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Disposable Infusion Pump Kit by Biomet, Inc. — 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
Biomet, Inc.

Sources (1)

  • FDA 510(k) K993972 24 fields · synced Jun 18, 2026