Device Classification Name |
Electrode, Cutaneous
|
510(k) Number |
K032278 |
Device Name |
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE |
Applicant |
AMBU, INC. |
611 NORTH HAMMONDS FERRY RD. |
LINTHICUM,
MD
21090 -1356
|
|
Applicant Contact |
SANJAY PARIKH |
Correspondent |
AMBU, INC. |
611 NORTH HAMMONDS FERRY RD. |
LINTHICUM,
MD
21090 -1356
|
|
Correspondent Contact |
SANJAY PARIKH |
Regulation Number | 882.1320
|
Classification Product Code |
|
Date Received | 07/24/2003 |
Decision Date | 03/05/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|