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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, monitoring, perinatal
510(k) Number K040788
Device Name CALM PATTERNS, VERSION 01.00.00
Applicant
LMS MEDICAL SYSTEMS LTD.
5252 DE MAISONNEUVE WEST, #314
MONTREAL, QC,  CA H4A 3S5
Applicant Contact PAMELA J HASWELL
Correspondent
LMS MEDICAL SYSTEMS LTD.
5252 DE MAISONNEUVE WEST, #314
MONTREAL, QC,  CA H4A 3S5
Correspondent Contact PAMELA J HASWELL
Regulation Number884.2740
Classification Product Code
HGM  
Date Received03/29/2004
Decision Date 02/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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