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FDA 510(k)

StealthConnect Remote Viewing, Planning and Collaboration System

K-Number: K162655 · 2017-04-21

Decision Date2017-04-21
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StealthConnect Remote Viewing, Planning and Collaboration System is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2017-04-21 under approval number K162655. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StealthConnect Remote Viewing, Planning and Collaboration System?

StealthConnect Remote Viewing, Planning and Collaboration System is a medical device that received FDA 510(k) clearance on 2017-04-21. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K162655.

When was StealthConnect Remote Viewing, Planning and Collaboration System approved by the FDA?

StealthConnect Remote Viewing, Planning and Collaboration System received FDA 510(k) clearance on 2017-04-21, under approval number K162655.

What company makes StealthConnect Remote Viewing, Planning and Collaboration System?

StealthConnect Remote Viewing, Planning and Collaboration System is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for StealthConnect Remote Viewing, Planning and Collaboration System?

The FDA product code for StealthConnect Remote Viewing, Planning and Collaboration System is HAW.

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Official Source

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