NAVIGATOR CLINICAL GUIDENCE SYSTEM— 510(k) K092219

Name: FDA 510(k) clearance K092219
Creator: U.S. Food and Drug Administration
Published: 2010-05-12

Substantially Equivalent

Applied Physiology Pty , Ltd.

FDA 510(k) clearance K092219 for NAVIGATOR CLINICAL GUIDENCE SYSTEM, Substantially Equivalent on 2010-05-12. Applicant: Applied Physiology Pty , Ltd.. Device class: 2.

Clearance details

Applicant: Applied Physiology Pty , Ltd.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2009-07-22
Decision date: 2010-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

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