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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 K150005
Device Name Checkpoint, Checkpoint Head & Neck
Applicant
Ndi Medical, LLC
22901 Millcreek Blvd. Suite 110
Cleveland,  OH  44122
Applicant Contact Robert Rogers
Correspondent
Ndi Medical, LLC
22901 Millcreek Blvd. Suite 110
Cleveland,  OH  44122
Correspondent Contact Robert Rogers
Regulation Number874.1820
Classification Product Code
ETN  
Date Received01/02/2015
Decision Date 02/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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