StealthStation Cranial Software V1.3.2

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 V1.3.2.

Pre-market Notification Details

Device IDK203639
510k NumberK203639
Device Name:StealthStation Cranial Software V1.3.2
ClassificationNeurological Stereotaxic Instrument
Applicant Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville,  CO  80027
ContactTaylor Gold West
CorrespondentTaylor Gold West
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 Received2020-12-14
Decision Date2021-01-13

NIH GUDID Devices

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