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Transducer Filter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K821268

by Cp Medical

Identifiers

510(k) Number
K821268 FDA 510(k)
FDA Product Code
FIB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5820 FDA 510(k)
Regulation Number
876.5820 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Transducer Filter by Cp Medical — 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
Cp Medical

Sources (1)

  • FDA 510(k) K821268 24 fields · synced Jun 18, 2026