VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER— 510(k) K022028

Name: FDA 510(k) clearance K022028
Creator: U.S. Food and Drug Administration
Published: 2002-12-17

Substantially Equivalent

Vascular One, Inc.

FDA 510(k) clearance K022028 for VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER, Substantially Equivalent on 2002-12-17. Applicant: Vascular One, Inc.. Device class: 2.

Clearance details

Applicant: Vascular One, Inc.
Product code: Code KPJ
Device class: Class 2
Regulation: 21 CFR 878.5650
Advisory panel: General, Plastic Surgery
Date received: 2002-06-21
Decision date: 2002-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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