Device Classification Name |
system, x-ray, stationary
|
510(k) Number |
K071546 |
Device Name |
EOS |
Applicant |
BIOSPACE MED |
555 THIRTEENTH ST. NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JOHN J SMITH |
Correspondent |
BIOSPACE MED |
555 THIRTEENTH ST. NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JOHN J SMITH |
Regulation Number | 892.1680
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/06/2007 |
Decision Date | 09/18/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|