Device Classification Name |
System, X-Ray, Stationary
|
510(k) Number |
K052943 |
Device Name |
DDRFORMULA AND DDRFORMULA PLUS |
Applicant |
SWISSRAY MEDICAL AG |
1180 MCLESTER STREET, UNIT #2 |
ELIZABETH,
NJ
07201
|
|
Applicant Contact |
JOHN MONAHAN |
Correspondent |
SWISSRAY MEDICAL AG |
1180 MCLESTER STREET, UNIT #2 |
ELIZABETH,
NJ
07201
|
|
Correspondent Contact |
JOHN MONAHAN |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 10/20/2005 |
Decision Date | 12/15/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|