AXIOM-HVG— 510(k) K955146

Name: FDA 510(k) clearance K955146
Creator: U.S. Food and Drug Administration
Published: 1996-05-17

Substantially Equivalent for Some Indications

Axiom Manufacturing

FDA 510(k) clearance K955146 for AXIOM-HVG, Substantially Equivalent for Some Indications on 1996-05-17. Applicant: Axiom Manufacturing. Device class: 2.

Clearance details

Applicant: Axiom Manufacturing
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 1995-11-13
Decision date: 1996-05-17
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

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