AXIOM EPS8000— 510(k) K050687

Substantially Equivalent

Axiom Worldwide, Inc.

FDA 510(k) clearance K050687 for AXIOM EPS8000, Substantially Equivalent on 2005-07-28. Applicant: Axiom Worldwide, Inc.. Device class: 2.

Clearance details

Applicant: Axiom Worldwide, Inc.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2005-03-17
Decision date: 2005-07-28
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.