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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 K121578
Device Name ATOM 1 (MODEL: BRC 2200)
Original Applicant
BIOELECTRIC RESEARCH CORPORATION
112 n. curry street
carson city,  NV  89703
Original Contact steven kaye
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/30/2012
Decision Date 07/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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