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Kitecko Ultrasound Standoff Pad

FDA 510(k)

Class II (US FDA 510(k))

510(k) K851982

by 3m Company

Identifiers

510(k) Number
K851982 FDA 510(k)
FDA Product Code
IYO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Kitecko Ultrasound Standoff Pad by 3m Company — 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
3m Company

Sources (1)

  • FDA 510(k) K851982 24 fields · synced Jun 18, 2026