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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 K110068
Device Name MODEL PM3030
Applicant
OMRON HEALTHCARE, INC.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
OMRON HEALTHCARE, INC.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number882.5890
Classification Product Code
NUH  
Date Received01/10/2011
Decision Date 12/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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