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FDA 510(k), K003759, AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
FDA 510(k), K003759, AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
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510(K) Number: K003759
Device Name: AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
Manufacturer: DAVID W SCHLERF
Device Classification Name: Device, Monitoring, Intracranial Pressure
Regulation Number: GWM
Classification Product Code: KXA
Date Received: 12/06/2000
Decision Date: 06/28/2001
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
Manufacturer: DAVID W SCHLERF
Device Classification Name: Device, Monitoring, Intracranial Pressure
Regulation Number: GWM
Classification Product Code: KXA
Date Received: 12/06/2000
Decision Date: 06/28/2001
Decision: 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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