StealthConnect Remote Viewing, Planning And Collaboration System

Neurological Stereotaxic Instrument

MEDTRONIC NAVIGATION, INC.

The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Stealthconnect Remote Viewing, Planning And Collaboration System.

Pre-market Notification Details

Device IDK162655
510k NumberK162655
Device Name:StealthConnect Remote Viewing, Planning And Collaboration System
ClassificationNeurological Stereotaxic Instrument
Applicant MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Louisville,  CO  80027
ContactMonica R. Montanez
CorrespondentMonica R. Montanez
MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Louisville,  CO  80027
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-23
Decision Date2017-04-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169705432 K162655 000

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