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FDA 510(k), K222519, ClearPoint System
FDA 510(k), K222519, ClearPoint System
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510(K) Number: K222519
Device Name: ClearPoint System
Manufacturer: ClearPoint Neuro, Inc.
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 08/19/2022
Decision Date: 09/16/2022
Regulation Medical Specialty: Neurology
Device Name: ClearPoint System
Manufacturer: ClearPoint Neuro, Inc.
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 08/19/2022
Decision Date: 09/16/2022
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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