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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nystagmograph
510(k) Number K182214
Device Name DizzyDoctor System 1.0.0
Applicant
Dizzydoctor Systems, LLC
7625 Mesa College Dr., Suite 200a
San Diego,  CA  92111
Applicant Contact Ian Purcell
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number882.1460
Classification Product Code
GWN  
Date Received08/15/2018
Decision Date 09/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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