FDA 510(k) Application Details - K993698

Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording

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510(K) Number K993698
Device Name Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant MOGUL ENTERPRISES
6387 SAN IGNACIO AVE.
SAN JOSE, CA 95119 US
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Contact JAMIL MOGUL
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Regulation Number 870.1220

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Classification Product Code DRF
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Date Received 11/02/1999
Decision Date 08/16/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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