Device Classification Name |
Index-Generating Electroencephalograph Software
|
510(k) Number |
K052145 |
Device Name |
DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES |
Applicant |
GE HEALTHCARE |
86 PILGRIM ROAD |
NEEDHAM,
MA
02492
|
|
Applicant Contact |
JOEL KENT |
Correspondent |
GE HEALTHCARE |
86 PILGRIM ROAD |
NEEDHAM,
MA
02492
|
|
Correspondent Contact |
JOEL KENT |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/08/2005 |
Decision Date | 08/23/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|