| Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
| 510(k) Number |
K874917 |
| Device Name |
PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM |
| Applicant |
| Oxford Medilog, Inc. |
| 11526 53rd. St. N. |
|
Clearwater,
FL
33520
|
|
| Applicant Contact |
MICHAEL J SMITH |
| Correspondent |
| Oxford Medilog, Inc. |
| 11526 53rd. St. N. |
|
Clearwater,
FL
33520
|
|
| Correspondent Contact |
MICHAEL J SMITH |
| Regulation Number | 870.1130 |
| Classification Product Code |
|
| Date Received | 12/03/1987 |
| Decision Date | 05/10/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|