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Topcon Model Trc-Nw200 Non-Mydriatic Retinal Camera

FDA 510(k)

Class II (US FDA 510(k))

510(k) K041367

by Topcon Corp.

Identifiers

510(k) Number
K041367 FDA 510(k)
FDA Product Code
HKI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.1120 FDA 510(k)
Regulation Number
886.1120 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Topcon Model Trc-Nw200 Non-Mydriatic Retinal Camera by Topcon Corp. — 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
Topcon Corp.

Sources (1)

  • FDA 510(k) K041367 24 fields · synced Jun 18, 2026