FDA 510(k)

SCIg60 Infuser

K-Number: K161906 · 2016-12-01

Decision Date2016-12-01

Product CodePKP

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SCIg60 Infuser is a medical device manufactured by Emed Technologies Corporation. It received FDA 510(k) clearance on 2016-12-01 under approval number K161906. The device is classified under product code PKP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCIg60 Infuser?

SCIg60 Infuser is a medical device that received FDA 510(k) clearance on 2016-12-01. It is manufactured by Emed Technologies Corporation. The 510(k) number is K161906.

When was SCIg60 Infuser approved by the FDA?

SCIg60 Infuser received FDA 510(k) clearance on 2016-12-01, under approval number K161906.

What company makes SCIg60 Infuser?

SCIg60 Infuser is manufactured by Emed Technologies Corporation.

What is the FDA product code for SCIg60 Infuser?

The FDA product code for SCIg60 Infuser is PKP.

Other Devices by Emed Technologies Corporation

K173783SCIg60 Infusion System K213429AccuSert Needle Inserter K222087SCIg60 Infusion System K230883VersaPump Infusion System K240148SCIg60 Infusion System K251105Tetra (TM-20); Tetra (TM-50)

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Related Devices (Code: PKP)

K173783SCIg60 Infusion SystemEmed Technologies Corporation K222087SCIg60 Infusion SystemEmed Technologies Corporation K230883VersaPump Infusion SystemEmed Technologies Corporation K240148SCIg60 Infusion SystemEmed Technologies Corporation K251105Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.