| Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
| 510(k) Number |
K843137 |
| Device Name |
BP 5000 |
| Applicant |
| Tech Vend Marketing |
| 6040 Dawson Blvd |
| Suite C-D |
|
Norcross ,
GA
30093
|
|
| Applicant Contact |
MICHAEL A GRAZIANO |
| Correspondent |
| Tech Vend Marketing |
| 6040 Dawson Blvd |
| Suite C-D |
|
Norcross ,
GA
30093
|
|
| Correspondent Contact |
MICHAEL A GRAZIANO |
| Regulation Number | 870.1130 |
| Classification Product Code |
|
| Date Received | 08/09/1984 |
| Decision Date | 01/16/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Clinical Chemistry
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|