GLAID OCULAR ELECTROPHYSIOLOGY DEVICE— 510(k) K043367

Name: FDA 510(k) clearance K043367
Creator: U.S. Food and Drug Administration
Published: 2005-11-17

Substantially Equivalent

Lace Electronica S.R.L.

FDA 510(k) clearance K043367 for GLAID OCULAR ELECTROPHYSIOLOGY DEVICE, Substantially Equivalent on 2005-11-17. Applicant: Lace Electronica S.R.L.. Device class: 2.

Clearance details

Applicant: Lace Electronica S.R.L.
Product code: Code GWE
Device class: Class 2
Regulation: 21 CFR 882.1890
Advisory panel: Neurology
Date received: 2004-12-08
Decision date: 2005-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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