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FDA 510(k) Application Details - K954479
Device Classification Name
System, Digital Image Communications, Radiological
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510(K) Number
K954479
Device Name
System, Digital Image Communications, Radiological
Applicant
HEARTLAB, INC.
146 WESTMINSTER ST.
SUITE 500
PROVIDENCE, RI 02903 US
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Contact
RICHARD PETROCELLI
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Regulation Number
892.2020
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Classification Product Code
LMD
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More FDA Info for this Product Code
Date Received
09/26/1995
Decision Date
02/21/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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