MB 11— 510(k) K011746

Substantially Equivalent

Maico Diagnostic GmbH

FDA 510(k) clearance K011746 for MB 11, Substantially Equivalent on 2001-08-24. Applicant: Maico Diagnostic GmbH. Device class: 2.

Clearance details

Applicant: Maico Diagnostic GmbH
Product code: Code GWJ
Device class: Class 2
Regulation: 21 CFR 882.1900
Advisory panel: Neurology
Date received: 2001-06-06
Decision date: 2001-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, 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.