Device Classification Name |
equipment, traction, powered
|
510(k) Number |
K010292 |
Device Name |
DRX 2000 |
Applicant |
AXIOM WORLDWIDE, INC. |
3830 GUNN HWY. |
TAMPA,
FL
33364
|
|
Applicant Contact |
JIM GIBSON |
Correspondent |
AXIOM WORLDWIDE, INC. |
3830 GUNN HWY. |
TAMPA,
FL
33364
|
|
Correspondent Contact |
JIM GIBSON |
Regulation Number | 890.5900
|
Classification Product Code |
|
Date Received | 01/31/2001 |
Decision Date | 05/01/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|