Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K111083 |
Device Name |
PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 |
Applicant |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
HEWLETT-PACKARD STR.2 |
BOEBLINGEN,
DE
D 71034
|
|
Applicant Contact |
MICHAEL ASMALSKY |
Correspondent |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
HEWLETT-PACKARD STR.2 |
BOEBLINGEN,
DE
D 71034
|
|
Correspondent Contact |
MICHAEL ASMALSKY |
Regulation Number | 884.2740
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/19/2011 |
Decision Date | 08/17/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|