Device Classification Name |
Standard Polysomnograph With Electroencephalograph
|
510(k) Number |
K012976 |
Device Name |
TWIN PLUS |
Applicant |
GRASS-TELEFACTOR DIVISON |
WEST-WARWICK,
RI
02893
|
|
Applicant Contact |
JOHN B CHATTEN |
Correspondent |
GRASS-TELEFACTOR DIVISON |
WEST-WARWICK,
RI
02893
|
|
Correspondent Contact |
JOHN B CHATTEN |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/05/2001 |
Decision Date | 02/12/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|