STATIC VESSEL ANALYZER— 510(k) K082196

Substantially Equivalent

Imedos GmbH

FDA 510(k) clearance K082196 for STATIC VESSEL ANALYZER, Substantially Equivalent on 2009-06-16. Applicant: Imedos GmbH. Device class: 2.

Clearance details

Applicant: Imedos GmbH
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2008-08-04
Decision date: 2009-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: League City, TX, 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.