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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K883845
Device Name RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER
Applicant
Phoenix Imaging
4666 S. Ash Ave.
Tempe,  AZ  85282
Applicant Contact MICHAEL PARSONS
Correspondent
Phoenix Imaging
4666 S. Ash Ave.
Tempe,  AZ  85282
Correspondent Contact MICHAEL PARSONS
Regulation Number870.2330
Classification Product Code
DXK  
Date Received09/12/1988
Decision Date 02/03/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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