Device Classification Name |
device, monitoring, intracranial pressure
|
510(k) Number |
K232890 |
Device Name |
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) |
Applicant |
Integra LifeSciences Production Corporation |
11 Cabot Boulevard |
Mansfield,
MA
02048
|
|
Applicant Contact |
Kali Sacco |
Correspondent |
Integra LifeSciences Production Corporation |
11 Cabot Boulevard |
Mansfield,
MA
02048
|
|
Correspondent Contact |
Kali Sacco |
Regulation Number | 882.1620
|
Classification Product Code |
|
Date Received | 09/18/2023 |
Decision Date | 02/04/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|