NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100


Device Classification Name

device, monitoring, intracranial pressure

510(k) Number K050720
Device Name NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
Applicant
INTEGRA NEUROSCIENCES
311 enterprise dr.
plainsboro, 
NJ 
08536

Applicant Contact nancy a mathewson
Correspondent
INTEGRA NEUROSCIENCES
311 enterprise dr.
plainsboro, 
NJ 
08536

Correspodent Contact nancy a mathewson
Regulation Number 882.1620
Classification Product Code
GWM  
Date Received 03/21/2005
Decision Date 05/11/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls