Device Classification Name |
Device, Biofeedback
|
510(k) Number |
K941959 |
Device Name |
VERSATELL; VERSATELL-S |
Applicant |
PROGRESSIVE CONCEPTS, INC. |
22194 HILLSBORO RD. |
DENTON,
MD
21629
|
|
Applicant Contact |
RAY FISCHER |
Correspondent |
PROGRESSIVE CONCEPTS, INC. |
22194 HILLSBORO RD. |
DENTON,
MD
21629
|
|
Correspondent Contact |
RAY FISCHER |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 04/22/1994 |
Decision Date | 06/21/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|