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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 K811572
Device Name ATL'S MARK 100/300 ULTRASOUND SYSTEMS
Applicant
ADVANCED TECHNOLOGY LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ADVANCED TECHNOLOGY LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number892.1560
Classification Product Code
IYO  
Date Received06/04/1981
Decision Date 08/10/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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