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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 Doppler, Ultrasonic
510(k) Number K893833
Device Name AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER
Applicant
Acoustic Imaging
4666 S. Ash Ave.
Tempe,  AZ  85282
Applicant Contact LORI CADWELL
Correspondent
Acoustic Imaging
4666 S. Ash Ave.
Tempe,  AZ  85282
Correspondent Contact LORI CADWELL
Regulation Number892.1550
Classification Product Code
IYN  
Date Received05/26/1989
Decision Date 09/11/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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