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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
510(k) Number K061365
Device Name CHECKPOINT WITH ACCUSTIM TECHNOLOGY
Applicant
Ndi Medical, LLC
One Chagrin Highlands 2000
Auburn Dr.,Suite 320
Cleveland,  OH  44122
Applicant Contact JULIE GRILL
Correspondent
Ndi Medical, LLC
One Chagrin Highlands 2000
Auburn Dr.,Suite 320
Cleveland,  OH  44122
Correspondent Contact JULIE GRILL
Regulation Number874.1820
Classification Product Code
ETN  
Date Received05/16/2006
Decision Date 07/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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