Device Classification Name |
Device, Biofeedback
|
510(k) Number |
K981844 |
Device Name |
SLEEP MANAGEMENT SYSTEM |
Applicant |
RMP, INC. |
601 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
TERRY G MAHN |
Correspondent |
RMP, INC. |
601 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
TERRY G MAHN |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 05/26/1998 |
Decision Date | 08/07/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|