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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K850137
Device Name TECA TC2-64 TRANSCRANIAL DOPPLER
Applicant
Teca, Inc.
Three Campus Dr.
Pleasantiville,  NY  10570
Applicant Contact EDWARD R SIROIS
Correspondent
Teca, Inc.
Three Campus Dr.
Pleasantiville,  NY  10570
Correspondent Contact EDWARD R SIROIS
Regulation Number870.2100
Classification Product Code
DPW  
Date Received01/14/1985
Decision Date 08/14/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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