Device Classification Name |
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
|
510(k) Number |
K121123 |
Device Name |
BIOFUSIONARY BEBE |
Applicant |
ROCKY MOUNTAIN BIOSYSTEMS, INC. |
3930 Youngfield Street |
Wheat Ridge,
CO
80033
|
|
Applicant Contact |
AMY BENEDICT |
Correspondent |
ROCKY MOUNTAIN BIOSYSTEMS, INC. |
3930 Youngfield Street |
Wheat Ridge,
CO
80033
|
|
Correspondent Contact |
AMY BENEDICT |
Regulation Number | 890.5290
|
Classification Product Code |
|
Date Received | 04/13/2012 |
Decision Date | 03/10/2014 |
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
|
|
|