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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 K895071
Device Name AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER
Applicant
Acoustic Imaging
4666 S. Ash Ave.
Tempe,  AZ  85282
Applicant Contact MICHAEL PARSONS
Correspondent
Acoustic Imaging
4666 S. Ash Ave.
Tempe,  AZ  85282
Correspondent Contact MICHAEL PARSONS
Regulation Number892.1560
Classification Product Code
IYO  
Date Received08/11/1989
Decision Date 10/12/1989
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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