FDA 510(k) Application Details - K040788

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K040788
Device Name System, Monitoring, Perinatal
Applicant LMS MEDICAL SYSTEMS LTD.
5252 DE MAISONNEUVE WEST, #314
MONTREAL, QC H4A 3S5 CA
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Contact PAMELA J HASWELL
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 03/29/2004
Decision Date 02/08/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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