Device Classification Name |
Oximeter
|
510(k) Number |
K900001 |
Device Name |
COROMETRICS MODEL 556 NEONATAL MONITOR |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
BRIAN R BARRY |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
BRIAN R BARRY |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 01/02/1990 |
Decision Date | 11/29/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|