Atlas FDA

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

FDA 510(k) clearance K050720 · decided 2005-05-11

Clearance details

K-number
K050720
Device name
NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
Applicant
Integra Neurosciences
Decision
Substantially Equivalent
Date received
2005-03-21
Decision date
2005-05-11
Days to decision
51 days
Clearance type
Special
Product code
GWM
Device class
2
Regulation number
882.1620
Medical specialty
Neurology
Advisory committee
Neurology
Location
Planisboro, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit recall (Z-0339-06)Integra Neuro Sciences2006-01-06