LUMOS, MODEL R 72B— 510(k) K093596

Substantially Equivalent

Lumos, Inc.

FDA 510(k) clearance K093596 for LUMOS, MODEL R 72B, Substantially Equivalent on 2010-01-12. Applicant: Lumos, Inc.. Device class: 2.

Clearance details

Applicant: Lumos, Inc.
Product code: Code KPW
Device class: Class 2
Regulation: 21 CFR 892.1610
Advisory panel: Radiology
Date received: 2009-11-20
Decision date: 2010-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.