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Thermostatic Water Mixing Valve Twv10

FDA 510(k)

Class II (US FDA 510(k))

510(k) K822874

by Gambro, Inc.

Identifiers

510(k) Number
K822874 FDA 510(k)
FDA Product Code
DWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4250 FDA 510(k)
Regulation Number
870.4250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Thermostatic Water Mixing Valve Twv10 by Gambro, 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
Gambro, Inc.

Sources (1)

  • FDA 510(k) K822874 24 fields · synced Jun 19, 2026