NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP— 510(k) K112634

Name: FDA 510(k) clearance K112634
Creator: U.S. Food and Drug Administration
Published: 2012-07-03

Substantially Equivalent

Inotec Amd , Ltd.

FDA 510(k) clearance K112634 for NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP, Substantially Equivalent on 2012-07-03. Applicant: Inotec Amd , Ltd.. Device class: 2.

Clearance details

Applicant: Inotec Amd , Ltd.
Product code: Code KPJ
Device class: Class 2
Regulation: 21 CFR 878.5650
Advisory panel: General, Plastic Surgery
Date received: 2011-09-09
Decision date: 2012-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfax, VA, US

Download summary PDF View on FDA.gov ↗

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