TANSCU O2— 510(k) K090681

Name: FDA 510(k) clearance K090681
Creator: U.S. Food and Drug Administration
Published: 2009-08-12

Substantially Equivalent

Electrochemical Oxygen Concepts, Inc.

FDA 510(k) clearance K090681 for TANSCU O2, Substantially Equivalent on 2009-08-12. Applicant: Electrochemical Oxygen Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Electrochemical Oxygen Concepts, Inc.
Product code: Code KPJ
Device class: Class 2
Regulation: 21 CFR 878.5650
Advisory panel: General, Plastic Surgery
Date received: 2009-03-16
Decision date: 2009-08-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Lake Bluff, IL, US

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