Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K060421 |
Device Name |
SONARA; SONARA/TEK |
Applicant |
VIASYS HEALTHCARE, INC. |
227 WASHINGTON ST. ' |
SUITE 200 |
CONSHOHOCKEN,
PA
19428
|
|
Applicant Contact |
GLEN HERMANSON |
Correspondent |
VIASYS HEALTHCARE, INC. |
227 WASHINGTON ST. ' |
SUITE 200 |
CONSHOHOCKEN,
PA
19428
|
|
Correspondent Contact |
GLEN HERMANSON |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/17/2006 |
Decision Date | 11/03/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|