The following data is part of a premarket notification filed by Aqueduct Critical Care, Inc. with the FDA for Smart External Drain (sed) System.
| Device ID | K181301 |
| 510k Number | K181301 |
| Device Name: | Smart External Drain (SED) System |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Aqueduct Critical Care, Inc. 11822 North Creek Parkway North Suite 110 Bothell, WA 98011 |
| Contact | Thomas Clement |
| Correspondent | Thomas Clement Aqueduct Critical Care, Inc. 11822 North Creek Parkway North Suite 110 Bothell, WA 98011 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-17 |
| Decision Date | 2018-06-14 |
| Summary: | summary |