| Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
| 510(k) Number |
K002046 |
| Device Name |
MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 |
| Applicant |
| Vsm Technology, Inc. |
| 555 13th St., NW |
|
Washington,
DC
20004 -1109
|
|
| Applicant Contact |
HOWARD M HOLSTEIN |
| Correspondent |
| Vsm Technology, Inc. |
| 555 13th St., NW |
|
Washington,
DC
20004 -1109
|
|
| Correspondent Contact |
HOWARD M HOLSTEIN |
| Regulation Number | 870.1130 |
| Classification Product Code |
|
| Date Received | 07/05/2000 |
| Decision Date | 07/21/2000 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Special
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|