Device Classification Name |
System, X-Ray, Mobile
|
510(k) Number |
K122697 |
Device Name |
PORTA 100HF |
Applicant |
JOB CORPORATION |
1411 W. 190TH STREET |
SUITE 120 |
GARDENA,
CA
92048
|
|
Applicant Contact |
TAKAHIRO HARUYAMA |
Correspondent |
JOB CORPORATION |
1411 W. 190TH STREET |
SUITE 120 |
GARDENA,
CA
92048
|
|
Correspondent Contact |
TAKAHIRO HARUYAMA |
Regulation Number | 892.1720
|
Classification Product Code |
|
Date Received | 09/04/2012 |
Decision Date | 10/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|