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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Spinal-Fluid Pressure, Electrically Powered
510(k) Number K920740
Device Name EPISENSOR PLUS
Applicant
Industrias Palex C/O Dma Med-Chem Corp.
Carretera De Terrassa 121
08191 Rubi. Barcelona
Spain,  ES
Applicant Contact ARCADI PRIETO
Correspondent
Industrias Palex C/O Dma Med-Chem Corp.
Carretera De Terrassa 121
08191 Rubi. Barcelona
Spain,  ES
Correspondent Contact ARCADI PRIETO
Regulation Number880.2460
Classification Product Code
CAR  
Date Received02/19/1992
Decision Date 03/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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