Smart External Drain (SED) System

Shunt, Central Nervous System And Components

Aqueduct Critical Care, Inc.

The following data is part of a premarket notification filed by Aqueduct Critical Care, Inc. with the FDA for Smart External Drain (sed) System.

Pre-market Notification Details

Device IDK181301
510k NumberK181301
Device Name:Smart External Drain (SED) System
ClassificationShunt, Central Nervous System And Components
Applicant Aqueduct Critical Care, Inc. 11822 North Creek Parkway North Suite 110 Bothell,  WA  98011
ContactThomas Clement
CorrespondentThomas Clement
Aqueduct Critical Care, Inc. 11822 North Creek Parkway North Suite 110 Bothell,  WA  98011
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-17
Decision Date2018-06-14
Summary:summary

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