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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 K042711
Device Name MODEL BMLS03-7
Applicant
Biomedical Life Systems, Inc.
P.O. Box 1360
Vista,  CA  92085
Applicant Contact GARY BUSSETT
Correspondent
Biomedical Life Systems, Inc.
P.O. Box 1360
Vista,  CA  92085
Correspondent Contact GARY BUSSETT
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
IPF   LIH  
Date Received09/30/2004
Decision Date 03/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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