Device Classification Name |
device, monitoring, intracranial pressure
|
510(k) Number |
K042728 |
Device Name |
CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM |
Applicant |
NOVUS MONITORING LTD |
311 ENTERPRISE DRIVE |
PLAINSBORO,
NJ
08536
|
|
Applicant Contact |
JUDITH E GRADY |
Correspondent |
NOVUS MONITORING LTD |
311 ENTERPRISE DRIVE |
PLAINSBORO,
NJ
08536
|
|
Correspondent Contact |
JUDITH E GRADY |
Regulation Number | 882.1620
|
Classification Product Code |
|
Date Received | 10/01/2004 |
Decision Date | 10/22/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|