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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 K954860
Device Name ECHONET
Applicant
HEARTLAB, INC.
146 WESTMINSTER ST.
SUITE 500
PROVIDENCE,  RI  02903
Applicant Contact RICHARD PETROCELLI
Correspondent
HEARTLAB, INC.
146 WESTMINSTER ST.
SUITE 500
PROVIDENCE,  RI  02903
Correspondent Contact RICHARD PETROCELLI
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/23/1995
Decision Date 12/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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