Device Classification Name |
Oximeter
|
510(k) Number |
K871353 |
Device Name |
OXIMETER |
Applicant |
RADIOMETER AMERICA, INC. |
811 SHARON DR. |
WESTLAKE,
OH
44145 -1598
|
|
Applicant Contact |
MARTIN A MILLER |
Correspondent |
RADIOMETER AMERICA, INC. |
811 SHARON DR. |
WESTLAKE,
OH
44145 -1598
|
|
Correspondent Contact |
MARTIN A MILLER |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 04/06/1987 |
Decision Date | 06/08/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|