STEALTHSTATION TREATMENT GUIDANCE PLATFORM

Neurological Stereotaxic Instrument

MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES

The following data is part of a premarket notification filed by Medtronic Surgical Navigation Technologies with the FDA for Stealthstation Treatment Guidance Platform.

Pre-market Notification Details

Device IDK003201
510k NumberK003201
Device Name:STEALTHSTATION TREATMENT GUIDANCE PLATFORM
ClassificationNeurological Stereotaxic Instrument
Applicant MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 826 Coal Creek Circle Louisville,  CO  80027
ContactRonald K Smith
CorrespondentRonald K Smith
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 826 Coal Creek Circle Louisville,  CO  80027
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-12
Decision Date2000-12-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.