INAREX, MODEL 2D-LX— 510(k) K080554

Substantially Equivalent

Inarex Corporation

FDA 510(k) clearance K080554 for INAREX, MODEL 2D-LX, Substantially Equivalent on 2008-08-27. Applicant: Inarex Corporation. Device class: 2.

Clearance details

Applicant: Inarex Corporation
Product code: Code JFB
Device class: Class 2
Regulation: 21 CFR 890.5880
Advisory panel: Physical Medicine
Date received: 2008-02-28
Decision date: 2008-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Mirada, CA, 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.