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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K963807
FOIA Releasable 510(k) K963807
Device Name TOMTEC ECHO-SCAN
Applicant
Tomtec Imaging Systems, Inc.
4775 Walnut St., Suite C
Boulder,  CO  80301
Applicant Contact KEVIN MORNINGSTAR
Correspondent
Tomtec Imaging Systems, Inc.
4775 Walnut St., Suite C
Boulder,  CO  80301
Correspondent Contact KEVIN MORNINGSTAR
Regulation Number892.1560
Classification Product Code
IYO  
Date Received09/23/1996
Decision Date 12/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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