Device Classification Name |
magnetoencephalograph
|
510(k) Number |
K962764 |
Device Name |
NEUROMAG-122 |
Applicant |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
5500 AVION PARK DR. |
HIGHLAND HEIGHTS,
OH
44143
|
|
Applicant Contact |
ELAINE K KEELER |
Correspondent |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
5500 AVION PARK DR. |
HIGHLAND HEIGHTS,
OH
44143
|
|
Correspondent Contact |
ELAINE K KEELER |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/16/1996 |
Decision Date | 10/31/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|