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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Monitoring, Intracranial Pressure
510(k) Number K020285
Device Name CMA CEREBRAL TISSUE MONITORING SYSTEM
Applicant
CMA MICRODIALYSIS AB
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact SHEILA HEMEON-HEYER
Correspondent
CMA MICRODIALYSIS AB
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact SHEILA HEMEON-HEYER
Regulation Number882.1620
Classification Product Code
GWM  
Date Received01/28/2002
Decision Date 10/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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