EYETECT TREMOR MONITOR UNIT (TMU)— 510(k) K003644

Substantially Equivalent

Eyetect, LLC

FDA 510(k) clearance K003644 for EYETECT TREMOR MONITOR UNIT (TMU), Substantially Equivalent on 2001-02-01. Applicant: Eyetect, LLC. Device class: 2.

Clearance details

Applicant: Eyetect, LLC
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 2000-11-27
Decision date: 2001-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belleville,, IL, 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.