Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K032956 |
Device Name |
ACCUSONIC A-SCAN MODEL, 24-4000 |
Applicant |
ACCUTOME, INC. |
263 GREAT VALLEY PKWY. |
MALVERN,
PA
19355
|
|
Applicant Contact |
JEFFREY L WRIGHT |
Correspondent |
ACCUTOME, INC. |
263 GREAT VALLEY PKWY. |
MALVERN,
PA
19355
|
|
Correspondent Contact |
JEFFREY L WRIGHT |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 09/22/2003 |
Decision Date | 10/10/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|