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FDA 510(k), K162309, StealthStation S8 System Platforms and StealthStation Cranial Software
FDA 510(k), K162309, StealthStation S8 System Platforms and StealthStation Cranial Software
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510(K) Number: K162309
Device Name: StealthStation S8 System Platforms and StealthStation Cranial Software
Manufacturer: Tia Fushimi-Bain
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: HAW
Classification Product Code: 08/17/2016
Date Received: 03/31/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: StealthStation S8 System Platforms and StealthStation Cranial Software
Manufacturer: Tia Fushimi-Bain
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: HAW
Classification Product Code: 08/17/2016
Date Received: 03/31/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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