FDA 510(k) Application Details - K990759

Device Classification Name System, Image Processing, Radiological

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510(K) Number K990759
Device Name System, Image Processing, Radiological
Applicant ELECTROMED INTL., LTD.
310 INDUSTRIAL BLVD.
ST-EUSTACHE, QUEBEC J7R 5R4 CA
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Contact PASCAL M KAUFMANN
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 03/08/1999
Decision Date 04/15/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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