DRX5000— 510(k) K023160

Substantially Equivalent

Axiom Usa., Inc.

FDA 510(k) clearance K023160 for DRX5000, Substantially Equivalent on 2002-12-20. Applicant: Axiom Usa., Inc.. Device class: 2.

Clearance details

Applicant: Axiom Usa., Inc.
Product code: Code ITH
Device class: Class 2
Regulation: 21 CFR 890.5900
Advisory panel: Physical Medicine
Date received: 2002-09-23
Decision date: 2002-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, 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.