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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 K991469
Device Name AWARE PAD
Applicant
Aac Consulting Group, Inc.
7475 Wisconsin Ave.,
Suite 850
Bethesda,  MD  20814
Applicant Contact EDUARDO MARCH
Correspondent
Aac Consulting Group, Inc.
7475 Wisconsin Ave.,
Suite 850
Bethesda,  MD  20814
Correspondent Contact EDUARDO MARCH
Regulation Number892.1560
Classification Product Code
IYO  
Date Received04/28/1999
Decision Date 07/20/1999
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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