Device Classification Name |
standard polysomnograph with electroencephalograph
|
510(k) Number |
K050425 |
Device Name |
AURA-PSG |
Applicant |
ASTRO-MED, INC. |
600 EAST GREENWICH AVE. |
WEST WARWICK,
RI
02893
|
|
Applicant Contact |
MICHAEL J SULLIVAN |
Correspondent |
ASTRO-MED, INC. |
600 EAST GREENWICH AVE. |
WEST WARWICK,
RI
02893
|
|
Correspondent Contact |
MICHAEL J SULLIVAN |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 02/18/2005 |
Decision Date | 10/20/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|