FDA 510(k) Application Details - K021823

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K021823
Device Name System, Tomography, Computed, Emission
Applicant NUCLEAR CARDIOLOGY SYSTEMS, INC.
5660 AIRPORT BLVD., SUITE 101
BOULDER, CO 80301 US
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Contact CHARLIE H ROSE
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 06/04/2002
Decision Date 06/17/2002
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 Y
Expedited Review



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