EDAC QUANTIFIER— 510(k) K071231

Substantially Equivalent

Luna Innovations, Inc.

FDA 510(k) clearance K071231 for EDAC QUANTIFIER, Substantially Equivalent on 2007-05-17. Applicant: Luna Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Luna Innovations, Inc.
Product code: Code KRL
Device class: Class 2
Regulation: 21 CFR 870.4205
Advisory panel: Cardiovascular
Date received: 2007-05-03
Decision date: 2007-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blacksburg, VA, 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.