Device Classification Name |
equipment, traction, powered
|
510(k) Number |
K022602 |
Device Name |
DRX3000 |
Applicant |
AXIOM USA. INC |
3830 GUNN HWY |
TAMPA,
FL
33624
|
|
Applicant Contact |
JIM GIBSON |
Correspondent |
AXIOM USA. INC |
3830 GUNN HWY |
TAMPA,
FL
33624
|
|
Correspondent Contact |
JIM GIBSON |
Regulation Number | 890.5900
|
Classification Product Code |
|
Date Received | 08/06/2002 |
Decision Date | 01/23/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|