Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K861544 |
Device Name |
MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM |
Applicant |
HEWLETT-PACKARD CO. |
SCHUCKARDSTRABE 4 |
7030 BOBLINGEN |
GERMANY,
DE
|
|
Applicant Contact |
LENKE |
Correspondent |
HEWLETT-PACKARD CO. |
SCHUCKARDSTRABE 4 |
7030 BOBLINGEN |
GERMANY,
DE
|
|
Correspondent Contact |
LENKE |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 04/24/1986 |
Decision Date | 07/18/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|