OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275— 510(k) K030737

Name: FDA 510(k) clearance K030737
Creator: U.S. Food and Drug Administration
Published: 2003-10-10

Substantially Equivalent

Ctf Systems (2001), Inc.

FDA 510(k) clearance K030737 for OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275, Substantially Equivalent on 2003-10-10. Applicant: Ctf Systems (2001), Inc.. Device class: 2.

Clearance details

Applicant: Ctf Systems (2001), Inc.
Product code: Code OLX
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2003-03-10
Decision date: 2003-10-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Port Coquitlam, B.C., CA

Download summary PDF View on FDA.gov ↗

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