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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 K000320
Device Name SONOS AIRES 600 (SA-600)
Applicant
Kpi Ultrasound, LLC
18626 S. Wilmington Ave.
# 100
Rancho Domingeus,  CA  90220
Applicant Contact STEVEN S MINN
Correspondent
Kpi Ultrasound, LLC
18626 S. Wilmington Ave.
# 100
Rancho Domingeus,  CA  90220
Correspondent Contact STEVEN S MINN
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received02/02/2000
Decision Date 05/02/2000
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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