StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)

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 Stealthstation Flexent (9736242), Stealthstation S8 Ent Software (9735762).

Pre-market Notification Details

Device IDK200723
510k NumberK200723
Device Name:StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
ClassificationEar, Nose, And Throat Stereotaxic Instrument
Applicant Medtronic Navigation Inc. 826 Coal Creek Circle Louisville,  CO  80027
ContactCarey Brenner
CorrespondentCarey Brenner
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 Received2020-03-19
Decision Date2020-06-26

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