FDA 510(k) Application Details - K042082

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K042082
Device Name System, Monitoring, Perinatal
Applicant MP4 SOLUTIONS, LP
11 LYNN BATTS LANE
SAN ANTONIO, TX 78218 US
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Contact WILLIAM CAMERON POWELL
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 08/03/2004
Decision Date 01/21/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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