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FDA 510(k)

NAVIGATOR CLINICAL GUIDENCE SYSTEM

K-Number: K092219 · 2010-05-12

ApplicantApplied Physiology Pty , Ltd.
Decision Date2010-05-12
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NAVIGATOR CLINICAL GUIDENCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Applied Physiology Pty , Ltd.. It received FDA 510(k) clearance on 2010-05-12 under 510(k) number K092219. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIGATOR CLINICAL GUIDENCE SYSTEM?

NAVIGATOR CLINICAL GUIDENCE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-05-12. The listed applicant is Applied Physiology Pty , Ltd.. The 510(k) number is K092219.

When did NAVIGATOR CLINICAL GUIDENCE SYSTEM receive FDA 510(k) clearance?

NAVIGATOR CLINICAL GUIDENCE SYSTEM received FDA 510(k) clearance on 2010-05-12, under 510(k) number K092219.

Who is the listed applicant for NAVIGATOR CLINICAL GUIDENCE SYSTEM?

The FDA 510(k) record lists Applied Physiology Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVIGATOR CLINICAL GUIDENCE SYSTEM?

The FDA product code for NAVIGATOR CLINICAL GUIDENCE SYSTEM is DXG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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