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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K051853
Device Name CARDIOSTREAM SONOAIM
Applicant
CARDIOSTREAM, LLC
2454 MCMULLEN BOOTH RD
STE 427
CLEARWATER,  FL  33759
Applicant Contact IAN P GORDON
Correspondent
CARDIOSTREAM, LLC
2454 MCMULLEN BOOTH RD
STE 427
CLEARWATER,  FL  33759
Correspondent Contact IAN P GORDON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/08/2005
Decision Date 08/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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