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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Photic, Evoked Response
510(k) Number K781398
Device Name TECA VS6 VIDEO STIMULATOR
Applicant
Teca, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Teca, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number882.1890
Classification Product Code
GWE  
Date Received08/15/1978
Decision Date 08/23/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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