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510(k) K062508

Device
NEUROWAVE MICRO-INFUSION SYSTEM
Applicant
EKOS CORP.
510(k) number
K062508
Product code
NUI  
Decision
Se - With Limitations (SESU)
Decision date
2006-12-05
Date received
2006-08-28
Regulation
870.1200
Classification name
Ultrasound, Infusion, System
Medical specialty
Cardiovascular
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOCELYN KERSTEN
Address
11911 N. Creek Pkwy. S. Bothell WA US 98011 98011

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NUI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K053437EKOS MICRO-INFUSION SYSTEMEkos Corp.2006-01-06
K051225EKOS MICRO-INFUSION SYSTEMEkos Corp.2005-06-10
K041826EKOS ULTRASOUND INFUSION SYSTEMEkos Corp.2005-04-27

Legacy Summary#

summary

FDA Review#

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