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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve, transcutaneous, for pain relief
510(k) Number K851185
Device Name ELECTRO-NERVE STIMULATOR B4/B400
Applicant
BIOMEDICAL LIFE SYSTEMS, INC.
P.O. BOX 39636
LOS ANGELES,  CA  90039
Applicant Contact RICHARD G SAXON
Correspondent
BIOMEDICAL LIFE SYSTEMS, INC.
P.O. BOX 39636
LOS ANGELES,  CA  90039
Correspondent Contact RICHARD G SAXON
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/01/1985
Decision Date 05/23/1985
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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