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Blackford Analysis Registration Product Family

FDA 510(k)

Class II (US FDA 510(k))

510(k) K142337

by Blackford Analysis, Ltd.

Identifiers

510(k) Number
K142337 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Blackford Analysis Registration Product Family by Blackford Analysis, Ltd. — 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

Sources (1)

  • FDA 510(k) K142337 24 fields · synced Jun 18, 2026