BRC SOFTWARE PRODUCT— 510(k) K050192

Name: FDA 510(k) clearance K050192
Creator: U.S. Food and Drug Administration
Published: 2005-10-20

Substantially Equivalent

Brc Operations Pty Limited

FDA 510(k) clearance K050192 for BRC SOFTWARE PRODUCT, Substantially Equivalent on 2005-10-20. Applicant: Brc Operations Pty Limited. Device class: 2.

Clearance details

Applicant: Brc Operations Pty Limited
Product code: Code OLU
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2005-01-27
Decision date: 2005-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianpolis, IN, US

Download summary PDF View on FDA.gov ↗

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