Device Classification Name |
Device, Monitoring, Intracranial Pressure
|
510(k) Number |
K083378 |
Device Name |
SYNERGY |
Applicant |
INNERSPACE, INC. |
1622 EDINGER AVENUE, SUITE C |
TUSTIN,
CA
92780
|
|
Applicant Contact |
DON BOBO |
Correspondent |
INNERSPACE, INC. |
1622 EDINGER AVENUE, SUITE C |
TUSTIN,
CA
92780
|
|
Correspondent Contact |
DON BOBO |
Regulation Number | 882.1620
|
Classification Product Code |
|
Date Received | 11/14/2008 |
Decision Date | 09/29/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|