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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 K945318
Device Name TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA
Applicant
Tetra Corp.
357 Inverness Dr. S.
Unit A
Englewood,  CO  80112
Applicant Contact O AKLEY
Correspondent
Tetra Corp.
357 Inverness Dr. S.
Unit A
Englewood,  CO  80112
Correspondent Contact O AKLEY
Regulation Number892.1570
Classification Product Code
ITX  
Date Received11/01/1994
Decision Date 05/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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