| Device Classification Name |
Probe, Blood-Flow, Extravascular
|
| 510(k) Number |
K873673 |
| Device Name |
BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL |
| Applicant |
| Sonicaid, Inc. |
| 11526 53rd.St. N. |
|
Clearwater,
FL
34620
|
|
| Applicant Contact |
ROBERT D WAXHAM |
| Correspondent |
| Sonicaid, Inc. |
| 11526 53rd.St. N. |
|
Clearwater,
FL
34620
|
|
| Correspondent Contact |
ROBERT D WAXHAM |
| Regulation Number | 870.2120 |
| Classification Product Code |
|
| Date Received | 09/11/1987 |
| Decision Date | 02/26/1988 |
| 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
|
|
|