Device Classification Name |
Device, Monitoring, Intracranial Pressure
|
510(k) Number |
K210993 |
Device Name |
CereLink ICP Monitor |
Applicant |
Integra LifeSciences Production Corporation |
11 Cabot Boulevard |
Mansfield,
MA
02048
|
|
Applicant Contact |
MaryBeth Carson |
Correspondent |
Integra LifeSciences Production Corporation |
11 Cabot Boulevard |
Mansfield,
MA
02048
|
|
Correspondent Contact |
MaryBeth Carson |
Regulation Number | 882.1620
|
Classification Product Code |
|
Date Received | 04/02/2021 |
Decision Date | 04/30/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|