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FDA 510(k)

STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE

K-Number: K081512 · 2008-07-18

ApplicantMedtronic Navigation, Inc.
Decision Date2008-07-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2008-07-18 under 510(k) number K081512. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE?

STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE is a medical device that received FDA 510(k) clearance on 2008-07-18. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K081512.

When did STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE receive FDA 510(k) clearance?

STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE received FDA 510(k) clearance on 2008-07-18, under 510(k) number K081512.

Who is the listed applicant for STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE?

The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE?

The FDA product code for STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE is LLZ.

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Official Source

View on FDA Database →

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

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