Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K965008 |
Device Name |
BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM |
Applicant |
SPACELABS MEDICAL, INC. |
925 SHERMAN AVE. |
HAMDEN,
CT
06514
|
|
Applicant Contact |
ANTHONY CALDERONI |
Correspondent |
SPACELABS MEDICAL, INC. |
925 SHERMAN AVE. |
HAMDEN,
CT
06514
|
|
Correspondent Contact |
ANTHONY CALDERONI |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 12/16/1996 |
Decision Date | 12/16/1997 |
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
|
Recalls |
CDRH Recalls
|
|
|