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FDA 510(k) Application Details - K974255
Device Classification Name
System, Digital Image Communications, Radiological
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510(K) Number
K974255
Device Name
System, Digital Image Communications, Radiological
Applicant
ELECTROMED INTL., LTD.
310 INDUSTRIAL BLVD.
ST-EUSTACHE, QUEBEC J7R 5R4 CA
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Contact
JAMES RIEDL
Other 510(k) Applications for this Contact
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
11/13/1997
Decision Date
01/27/1998
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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