Device Classification Name |
Standard Polysomnograph With Electroencephalograph
|
510(k) Number |
K001013 |
Device Name |
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY |
Applicant |
AIRSEP CORP. |
290 CREEKSIDE DR. |
BUFFALO,
NY
14228
|
|
Applicant Contact |
PETER WEISENBORN |
Correspondent |
AIRSEP CORP. |
290 CREEKSIDE DR. |
BUFFALO,
NY
14228
|
|
Correspondent Contact |
PETER WEISENBORN |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/29/2000 |
Decision Date | 05/16/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|