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FDA 510(k), K101133, SENSOMETRICS SOFTWARE
FDA 510(k), K101133, SENSOMETRICS SOFTWARE
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510(K) Number: K101133
Device Name: SENSOMETRICS SOFTWARE
Manufacturer: DPCOM AS
Device Classification Name: device, monitoring, intracranial pressure
Regulation Number: 882.1620
Classification Product Code: GWM
Date Received: 04/22/2010
Decision Date: 11/18/2010
Regulation Medical Specialty: Neurology
Device Name: SENSOMETRICS SOFTWARE
Manufacturer: DPCOM AS
Device Classification Name: device, monitoring, intracranial pressure
Regulation Number: 882.1620
Classification Product Code: GWM
Date Received: 04/22/2010
Decision Date: 11/18/2010
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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