Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K062137 |
Device Name |
MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 |
Applicant |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HEWLETT-PACKARD STR.2 |
BOEBLINGEN, BADEN-WTTBG,
DE
D 71034
|
|
Applicant Contact |
MARKUS STACHA |
Correspondent |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HEWLETT-PACKARD STR.2 |
BOEBLINGEN, BADEN-WTTBG,
DE
D 71034
|
|
Correspondent Contact |
MARKUS STACHA |
Regulation Number | 884.2740
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/26/2006 |
Decision Date | 08/24/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|