Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K231283 |
Device Name |
SiteRite™ 9 Ultrasound System |
Applicant |
Bard Access Systems, Inc. (C.R. Bard, Inc.) |
605 North 5600 West |
Salt Lake City,
UT
84116
|
|
Applicant Contact |
Fabio De Pasquale |
Correspondent |
Bard Access Systems, Inc. (C.R. Bard, Inc.) |
605 North 5600 West |
Salt Lake City,
UT
84116
|
|
Correspondent Contact |
Fabio De Pasquale |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/03/2023 |
Decision Date | 09/11/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|