| Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
| 510(k) Number |
K032492 |
| Device Name |
BLOOD PRESSURE MONITOR, MODEL KP-7000 |
| Applicant |
| K-Jump Health Co., Ltd. |
| 555 Thirteenth St. NW |
|
Washington,
DC
20004
|
|
| Applicant Contact |
JONATHAN S KAHAN |
| Correspondent |
| K-Jump Health Co., Ltd. |
| 555 Thirteenth St. NW |
|
Washington,
DC
20004
|
|
| Correspondent Contact |
JONATHAN S KAHAN |
| Regulation Number | 870.1130 |
| Classification Product Code |
|
| Date Received | 08/12/2003 |
| Decision Date | 09/09/2003 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Summary |
Summary
|
| Type |
Special
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|