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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 K031358
Device Name TRANSVAGINAL DOPPLER PROBE
Applicant
Vascular Control Systems, Inc.
32236 Paseo Adelanto, Suite E
San Juan Capistrano,  CA  92675
Applicant Contact KATHLEEN ROBERTS
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact HEINZ-JOERG SENEBERG
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/30/2003
Decision Date 05/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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