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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
510(k) Number K071730
Device Name STUDIODOP VICORDER
Applicant
Skidmore Medical, Limited
7744 Swaps Trl.
Evergreen,  CO  80439
Applicant Contact DAVID W WAGNER
Correspondent
Skidmore Medical, Limited
7744 Swaps Trl.
Evergreen,  CO  80439
Correspondent Contact DAVID W WAGNER
Regulation Number870.2880
Classification Product Code
JOP  
Date Received06/25/2007
Decision Date 12/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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