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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 K801755
Device Name MMI/GAELTEC CATHETER TIP PRESSURE
Applicant
MEDICAL MEASUREMENTS, INC.
NJ 
Correspondent
MEDICAL MEASUREMENTS, INC.
NJ 
Regulation Number882.1620
Classification Product Code
GWM  
Date Received07/28/1980
Decision Date 08/13/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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