| Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
|---|
| 510(k) Number |
K003292 |
|---|
| Device Name |
260 CORVUS |
|---|
| Applicant |
| PIE MEDICAL |
| 7992 CASTLEWAY DRIVE |
|
INDIANAPOLIS,
IN
46250
|
|
| Applicant Contact |
COLLEEN J HITTLE |
| Correspondent |
| PIE MEDICAL |
| 7992 CASTLEWAY DRIVE |
|
INDIANAPOLIS,
IN
46250
|
|
| Correspondent Contact |
COLLEEN J HITTLE |
| Regulation Number | 892.1560
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 10/20/2000 |
|---|
| Decision Date | 01/05/2001 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Radiology
|
|---|
| 510k Review Panel |
Radiology
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|