Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
510(k) Number |
K003141 |
Device Name |
UBM PLUS, MODEL P45 |
Applicant |
PARADIGM MEDICAL INDUSTRIES, INC. |
2355 SOUTH 1070 WEST |
SALT LAKE CITY,
UT
84119
|
|
Applicant Contact |
TRACY S BEST |
Correspondent |
PARADIGM MEDICAL INDUSTRIES, INC. |
2355 SOUTH 1070 WEST |
SALT LAKE CITY,
UT
84119
|
|
Correspondent Contact |
TRACY S BEST |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 10/10/2000 |
Decision Date | 12/05/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|