Device Classification Name |
Device, Sleep Assessment
|
510(k) Number |
K965079 |
Device Name |
SOMNITOR 32K SLEEP ACTIVITY MONITOR |
Applicant |
NEURIM PHARMACEUTICALS, LTD. |
12300 TWINBROOK PARKWAY, SUIT5 |
ROCKVILLE,
MD
20852
|
|
Applicant Contact |
T. WHIT ATHEY |
Correspondent |
NEURIM PHARMACEUTICALS, LTD. |
12300 TWINBROOK PARKWAY, SUIT5 |
ROCKVILLE,
MD
20852
|
|
Correspondent Contact |
T. WHIT ATHEY |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 12/19/1996 |
Decision Date | 07/10/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|