Device Classification Name |
Device, Monitoring, Intracranial Pressure
|
510(k) Number |
K912139 |
Device Name |
MODEL 704 |
Applicant |
IVY BIOMEDICAL SYSTEMS, INC. |
11 BUSINESS PARK DR. |
BRANFORD,
CT
06405
|
|
Applicant Contact |
STEVEN M.SIMON |
Correspondent |
IVY BIOMEDICAL SYSTEMS, INC. |
11 BUSINESS PARK DR. |
BRANFORD,
CT
06405
|
|
Correspondent Contact |
STEVEN M.SIMON |
Regulation Number | 882.1620
|
Classification Product Code |
|
Date Received | 05/14/1991 |
Decision Date | 03/25/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|