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FDA 510(k), K182417, ROSA ONE Brain Application
FDA 510(k), K182417, ROSA ONE Brain Application
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$149.00 USD
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510(K) Number: K182417
Device Name: ROSA ONE Brain Application
Manufacturer: Serge Tabet
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: HAW
Classification Product Code: 09/05/2018
Date Received: 02/07/2019
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: 09/05/2018
Date Received: 02/07/2019
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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