PREMIER PLUS— 510(k) K032003

Substantially Equivalent

American Imex

FDA 510(k) clearance K032003 for PREMIER PLUS, Substantially Equivalent on 2004-01-07. Applicant: American Imex. Device class: 2.

Clearance details

Applicant: American Imex
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2003-06-27
Decision date: 2004-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from American Imex

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