Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K921956 |
Device Name |
HEWLETT PACKARD MODEL M1353A FETAL MONITOR |
Applicant |
HEWLETT-PACKARD CO. |
SCHUCKARDSTRABE 4 |
7030 BOBLINGEN |
GERMANY,
DE
|
|
Applicant Contact |
ERICH COURTIN |
Correspondent |
HEWLETT-PACKARD CO. |
SCHUCKARDSTRABE 4 |
7030 BOBLINGEN |
GERMANY,
DE
|
|
Correspondent Contact |
ERICH COURTIN |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 04/27/1992 |
Decision Date | 09/24/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|