FDA 510(k) Application Details - K915592

Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified

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510(K) Number K915592
Device Name System, X-Ray, Fluoroscopic, Image-Intensified
Applicant FISCHER IMAGING CORP.
12300 NORTH GRANT ST.
DENVER, CO US
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Contact JAMES MORGAN
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Regulation Number 892.1650

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Classification Product Code JAA
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Date Received 12/13/1991
Decision Date 01/13/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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