Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K003725 |
Device Name |
240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS |
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 | 12/04/2000 |
Decision Date | 03/01/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|