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FDA 510(k)

SCIg60 Infusion System

K-Number: K173783 · 2018-12-14

ApplicantEmed Technologies Corporation
Decision Date2018-12-14
Product CodePKP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SCIg60 Infusion System is a medical device manufactured by Emed Technologies Corporation. It received FDA 510(k) clearance on 2018-12-14 under approval number K173783. 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 Infusion System?

SCIg60 Infusion System is a medical device that received FDA 510(k) clearance on 2018-12-14. It is manufactured by Emed Technologies Corporation. The 510(k) number is K173783.

When was SCIg60 Infusion System approved by the FDA?

SCIg60 Infusion System received FDA 510(k) clearance on 2018-12-14, under approval number K173783.

What company makes SCIg60 Infusion System?

SCIg60 Infusion System is manufactured by Emed Technologies Corporation.

What is the FDA product code for SCIg60 Infusion System?

The FDA product code for SCIg60 Infusion System is PKP.

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Other Devices by Emed Technologies Corporation

K161906SCIg60 Infuser 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)

K161906SCIg60 InfuserEmed 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

View on FDA Database →

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

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