FDA 510(k) Application Details - K080798

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K080798
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant INTEL CORP.
1900 PRAIRIE CITY RD., FM7-197
FOLSOM, CA 95630 US
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Contact TAE-WOONG KOO
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 03/20/2008
Decision Date 06/27/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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