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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K932596
Device Name NT4-PLUS
Applicant
Bmr Ent., Inc.
Industrial Est
Bunbeg, Co Donegal
Ireland,  IR
Applicant Contact MICHAEL HEAVEY
Correspondent
Bmr Ent., Inc.
Industrial Est
Bunbeg, Co Donegal
Ireland,  IR
Correspondent Contact MICHAEL HEAVEY
Regulation Number890.5850
Classification Product Code
IPF  
Date Received05/28/1993
Decision Date 08/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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