| Device Classification Name |
Device, Monitoring, Intracranial Pressure
|
| 510(k) Number |
K801755 |
| Device Name |
MMI/GAELTEC CATHETER TIP PRESSURE |
| Applicant |
| Medical Measurements, Inc. |
| . |
|
Nutley,
NJ
|
|
| Correspondent |
| Medical Measurements, Inc. |
| . |
|
Nutley,
NJ
|
|
| Regulation Number | 882.1620 |
| Classification Product Code |
|
| Date Received | 07/28/1980 |
| Decision Date | 08/13/1980 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|