| Device Classification Name |
Computer, Blood-Pressure
|
| 510(k) Number |
K893232 |
| Device Name |
MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM |
| Applicant |
| Camino Laboratories, Inc. |
| 5955 Pacific Center Blvd. |
|
San Diego,
CA
92121
|
|
| Applicant Contact |
HAZEL SHUMWAY |
| Correspondent |
| Camino Laboratories, Inc. |
| 5955 Pacific Center Blvd. |
|
San Diego,
CA
92121
|
|
| Correspondent Contact |
HAZEL SHUMWAY |
| Regulation Number | 870.1110 |
| Classification Product Code |
|
| Date Received | 04/28/1989 |
| Decision Date | 07/14/1989 |
| 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
|
|
|