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510(k) K041826

Device
EKOS ULTRASOUND INFUSION SYSTEM
Applicant
EKOS CORP.
510(k) number
K041826
Product code
NUI  
Decision
Se - With Limitations (SESU)
Decision date
2005-04-27
Date received
2004-07-07
Regulation
870.1200
Classification name
Ultrasound, Infusion, System
Medical specialty
Cardiovascular
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOCELYN KERSTEN
Address
22030 20th Ave. SE Suite 101 Bothell WA US 98021 98021

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NUI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K062508NEUROWAVE MICRO-INFUSION SYSTEMEkos Corp.2006-12-05
K053437EKOS MICRO-INFUSION SYSTEMEkos Corp.2006-01-06
K051225EKOS MICRO-INFUSION SYSTEMEkos Corp.2005-06-10

Legacy Summary#

summary

FDA Review#

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