FDA 510(k) Application Details - K102135

Device Classification Name Medical Computers And Software

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510(K) Number K102135
Device Name Medical Computers And Software
Applicant NUVON, INC.
555 THIRTEENTH STREET NW
WASHINGTON, DC 20004 US
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Contact JONATHAN S KAHAN
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Regulation Number 000.0000

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Classification Product Code LNX
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Date Received 07/29/2010
Decision Date 10/22/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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