Device Classification Name |
standard polysomnograph with electroencephalograph
|
510(k) Number |
K992291 |
Device Name |
H20- TETHERED OPTION |
Applicant |
GRASS-TELEFACTOR PRODUCT GROUP |
1094 NEW DEHAVEN AVE. |
WEST CONSHOHOCKEN,
PA
19428
|
|
Applicant Contact |
JAMES S BRYAN |
Correspondent |
GRASS-TELEFACTOR PRODUCT GROUP |
1094 NEW DEHAVEN AVE. |
WEST CONSHOHOCKEN,
PA
19428
|
|
Correspondent Contact |
JAMES S BRYAN |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/07/1999 |
Decision Date | 08/06/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|