Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K954351 |
Device Name |
SERIES 50XM |
Applicant |
HEWLETT-PACKARD GMBH |
SCHICKARD STRASSE 4 |
BOEBLINGEN |
WUERTTEMBERG,
DE
71034
|
|
Applicant Contact |
MONICA FERRANTE |
Correspondent |
HEWLETT-PACKARD GMBH |
SCHICKARD STRASSE 4 |
BOEBLINGEN |
WUERTTEMBERG,
DE
71034
|
|
Correspondent Contact |
MONICA FERRANTE |
Regulation Number | 884.2740
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/18/1995 |
Decision Date | 03/08/1996 |
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
|
|
|