Device Classification Name |
System, X-Ray, Stationary
|
510(k) Number |
K121345 |
Device Name |
SR SUITE 1.0 |
Applicant |
HALIFAX BIOMEDICAL, INC. |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
HALIFAX BIOMEDICAL, INC. |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 892.1680
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/04/2012 |
Decision Date | 06/01/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|