Device Classification Name |
transducer, ultrasonic, diagnostic
|
510(k) Number |
K011265 |
Device Name |
ULTRASOUND TRANSDUCER COVER |
Applicant |
ADVANCE MEDICAL DESIGNS, INC. |
1241 ATLANTA INDUSTRIAL DR. |
MARIETTA,
GA
30066
|
|
Applicant Contact |
BILL GILL |
Correspondent |
ADVANCE MEDICAL DESIGNS, INC. |
1241 ATLANTA INDUSTRIAL DR. |
MARIETTA,
GA
30066
|
|
Correspondent Contact |
BILL GILL |
Regulation Number | 892.1570
|
Classification Product Code |
|
Date Received | 04/25/2001 |
Decision Date | 10/30/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|