Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K052715 |
Device Name |
CALM CURVE, VERSION 01.00 |
Applicant |
LMS MEDICAL SYSTEMS (CANADA), LTD. |
5252 DE MAISONNEUVE WEST, #314 |
MONTREAL, QC,
CA
H4A 3S5
|
|
Applicant Contact |
PAMELA HASWELL |
Correspondent |
LMS MEDICAL SYSTEMS (CANADA), LTD. |
5252 DE MAISONNEUVE WEST, #314 |
MONTREAL, QC,
CA
H4A 3S5
|
|
Correspondent Contact |
PAMELA HASWELL |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 09/29/2005 |
Decision Date | 12/22/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|