StealthStation Cranial Software V1.3.0

Neurological Stereotaxic Instrument

Medtronic Navigation Inc.

The following data is part of a premarket notification filed by Medtronic Navigation Inc. with the FDA for Stealthstation Cranial Software V1.3.0.

Pre-market Notification Details

Device IDK201175
510k NumberK201175
Device Name:StealthStation Cranial Software V1.3.0
ClassificationNeurological Stereotaxic Instrument
Applicant Medtronic Navigation Inc. 826 Coal Creek Circle Louisville,  CO  80027
ContactAmelia Striegel
CorrespondentAmelia Striegel
Medtronic Navigation Inc. 826 Coal Creek Circle Louisville,  CO  80027
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-01
Decision Date2020-06-03

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