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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 K972244
Device Name NT2000
Applicant
Bio-Medical Research, Ltd.
14900 Sweitzer Ln.
Suite 200
Laurel,  MD  20707
Applicant Contact GREG SHIPP
Correspondent
Bio-Medical Research, Ltd.
14900 Sweitzer Ln.
Suite 200
Laurel,  MD  20707
Correspondent Contact GREG SHIPP
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/16/1997
Decision Date 02/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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