Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K030223 |
Device Name |
SONOCALC |
Applicant |
SONOMETRIC HEALTH, LLC |
1373 E. SKYLINE DR. |
BOUNTIFUL,
UT
84010
|
|
Applicant Contact |
HELMUT FRITZ |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Correspondent Contact |
NED E DEVINE |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 01/22/2003 |
Decision Date | 02/06/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|