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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, over-the-counter
510(k) Number K172079
Device Name Avail
Omron Healthcare, Inc.
1925 West Field Court
lake forest,  IL  60045
Applicant Contact renee thornborough
Experien Group
224 Airport Parkway, Suite 250
san jose,  CA  95110
Correspondent Contact ronald s. warren
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
Date Received07/10/2017
Decision Date 10/19/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No