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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 K982173
Device Name BUZBEE
Applicant
Mwr Electronics Industrial Co.
21 Rose Rd.
Goodwood, Capetown,  ZA
Applicant Contact MANFRED W ROSCHER
Correspondent
Mwr Electronics Industrial Co.
21 Rose Rd.
Goodwood, Capetown,  ZA
Correspondent Contact MANFRED W ROSCHER
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/19/1998
Decision Date 03/11/1999
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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