ELEXOMA MEDIC— 510(k) K070412

Substantially Equivalent

Redplane AG

FDA 510(k) clearance K070412 for ELEXOMA MEDIC, Substantially Equivalent on 2008-05-21. Applicant: Redplane AG. Device class: 2.

Clearance details

Applicant: Redplane AG
Product code: Code QJQ
Device class: Class 2
Regulation: 21 CFR 882.5800
Advisory panel: Neurology
Date received: 2007-02-12
Decision date: 2008-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zug, CH

Download summary PDF View on FDA.gov ↗

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