Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K181301 |
Device Name |
Smart External Drain (SED) System |
Applicant |
Aqueduct Critical Care, Inc. |
11822 North Creek Parkway North |
Suite 110 |
Bothell,
WA
98011
|
|
Applicant Contact |
Thomas Clement |
Correspondent |
Aqueduct Critical Care, Inc. |
11822 North Creek Parkway North |
Suite 110 |
Bothell,
WA
98011
|
|
Correspondent Contact |
Thomas Clement |
Regulation Number | 882.5550
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/17/2018 |
Decision Date | 06/14/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|