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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K010883
Device Name TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE
Applicant
Teratech Corp.
19030 Portos Dr.
Saratoga,  CA  95070
Applicant Contact CHARLES F HOTTINGER
Correspondent
Tuv Product Service, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Regulation Number892.1570
Classification Product Code
ITX  
Date Received03/23/2001
Decision Date 04/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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