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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 K173780
Device Name EchoMD Automated Ejection Fraction Software
Applicant
Bay Labs, Inc.
290 King Street
San Francisco,  CA  94107
Applicant Contact Charles Cadieu
Correspondent
Hogan Lovells US LLP
3 Embarcadero Center
Suite 1500
San Francisco,  CA  94111
Correspondent Contact Yarmela Pavlovic
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/12/2017
Decision Date 06/14/2018
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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