Device Classification Name |
Lamp, Infrared, Therapeutic Heating
|
510(k) Number |
K974468 |
Device Name |
PHOTONIC STIMULATOR |
Applicant |
BALES SCIENTIFIC, INC. |
1620 TICE VALLEY BLVD., #250 |
WALNUT CREEK,
CA
94595
|
|
Applicant Contact |
MAURICE BALES |
Correspondent |
BALES SCIENTIFIC, INC. |
1620 TICE VALLEY BLVD., #250 |
WALNUT CREEK,
CA
94595
|
|
Correspondent Contact |
MAURICE BALES |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 11/26/1997 |
Decision Date | 06/22/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|