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FDA 510(k), K200511, ROSA ONE Brain application
FDA 510(k), K200511, ROSA ONE Brain application
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510(K) Number: K200511
Device Name: ROSA ONE Brain application
Manufacturer: Serge Tabet
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: HAW
Classification Product Code: 03/02/2020
Date Received: 05/29/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: ROSA ONE Brain application
Manufacturer: Serge Tabet
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: HAW
Classification Product Code: 03/02/2020
Date Received: 05/29/2020
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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