Device Classification Name |
Device, Monitoring, Intracranial Pressure
|
510(k) Number |
K003759 |
Device Name |
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR |
Applicant |
AESCULAP, INC. |
200 GREGORY LN. |
SUITE C-100 |
PLEASENT HILL,
CA
94523 -3389
|
|
Applicant Contact |
DAVID W SCHLERF |
Correspondent |
AESCULAP, INC. |
200 GREGORY LN. |
SUITE C-100 |
PLEASENT HILL,
CA
94523 -3389
|
|
Correspondent Contact |
DAVID W SCHLERF |
Regulation Number | 882.1620
|
Classification Product Code |
|
Date Received | 12/06/2000 |
Decision Date | 06/28/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|