StealthStationTM S8 ENT Software

Ear, Nose, And Throat Stereotaxic Instrument

Medtronic Navigation, Inc.

The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Stealthstationtm S8 Ent Software.

Pre-market Notification Details

Device IDK170018
510k NumberK170018
Device Name:StealthStationTM S8 ENT Software
ClassificationEar, Nose, And Throat Stereotaxic Instrument
Applicant Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville,  CO  80027
ContactK. Elizabeth Waite
CorrespondentK. Elizabeth Waite
Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville,  CO  80027
Product CodePGW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-03
Decision Date2017-05-19
Summary:summary

NIH GUDID Devices

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