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510(k) K161906

Device
SCIg60 Infuser
Applicant
EMED TECHNOLOGIES CORPORATION
510(k) number
K161906
Product code
PKP  
Decision
Substantially Equivalent (SESE)
Decision date
2016-12-01
Date received
2016-07-12
Regulation
880.5725
Classification name
Immunoglobulin G (igg) Infusion System
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PETER KOLLINGS
Address
1264 Hawks Flight Ct., Suite 200 El Dorado Hills CA US 95762 95762

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PKP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251105Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation2025-12-22
K240148SCIg60 Infusion SystemEmed Technologies Corporation2024-02-16
K230883VersaPump Infusion SystemEmed Technologies Corporation2023-11-28
K222087SCIg60 Infusion SystemEmed Technologies Corporation2022-10-13
K173783SCIg60 Infusion SystemEmed Technologies Corporation2018-12-14
K142319SCIg60 Infuser, InfusetEmed Technologies Corporation2015-05-14

Legacy Summary#

summary

FDA Review#

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