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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 K890468
Device Name MODEL FT-100 INTRACRANIAL PRESSURE MONITOR
Applicant
Pearl Instruments Corp.
3382 Dato Ave.
Highland Park,  IL  60035
Applicant Contact ALFRED R PERLIN,PHD
Correspondent
Pearl Instruments Corp.
3382 Dato Ave.
Highland Park,  IL  60035
Correspondent Contact ALFRED R PERLIN,PHD
Regulation Number882.1620
Classification Product Code
GWM  
Date Received01/31/1989
Decision Date 04/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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