Device Classification Name |
Standard Polysomnograph With Electroencephalograph
|
510(k) Number |
K010728 |
FOIA Releasable 510(k) |
K010728
|
Device Name |
HARMONE-SCHWARZER EEG SYSTEM |
Applicant |
STELLATE SYSTEMS |
345 VICTORIA AVE., SUITE 300 |
WESTMOUNT, QUEBEC,
CA
H3Z 2N2
|
|
Applicant Contact |
GEORGE PAPAGIANNIS |
Correspondent |
STELLATE SYSTEMS |
345 VICTORIA AVE., SUITE 300 |
WESTMOUNT, QUEBEC,
CA
H3Z 2N2
|
|
Correspondent Contact |
GEORGE PAPAGIANNIS |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/12/2001 |
Decision Date | 05/21/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|