Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K021135 |
Device Name |
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
JOELLE NEIDER |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
JOELLE NEIDER |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 04/09/2002 |
Decision Date | 05/09/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|