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FDA 510(k) Applications Submitted by Shane Sawall
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180421
02/16/2018
Natus NeuroWorks
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
K192368
08/30/2019
CATSmart
Fresenius Kabi AG
K173690
12/01/2017
Grass TWin
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
K130346
02/11/2013
SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION
NATUS NEUROLOGY INCORPORATED
K163617
12/22/2016
REMbrandt
Embla Systems
K162140
08/01/2016
RemLogic
EMBLA SYSTEMS
K172743
09/12/2017
Natus VikingQuest
Natus Neurology Incorporated
K173366
10/26/2017
NicoletOne
Natus Neurology Incorporated
K153353
11/20/2015
SANDMAN ELITE
EMBLA SYSTEMS
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