Device Classification Name |
Oximeter
|
510(k) Number |
K902192 |
Device Name |
MODEL MSC SA02-5000 PULSE OXIMETER |
Applicant |
MEDICAL SYSTEMS CORP. |
ONE PLAZA RD. |
GREENVALE,
NY
11548 -9801
|
|
Applicant Contact |
MARDIN VARELA |
Correspondent |
MEDICAL SYSTEMS CORP. |
ONE PLAZA RD. |
GREENVALE,
NY
11548 -9801
|
|
Correspondent Contact |
MARDIN VARELA |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 05/16/1990 |
Decision Date | 08/23/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|