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FDA 510(k)

SCIg60 Infuser

K-Number: K161906 · 2016-12-01

ApplicantEmed Technologies Corporation
Decision Date2016-12-01
Product CodePKP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SCIg60 Infuser is the device name listed in this FDA 510(k) record. The listed applicant is Emed Technologies Corporation. It received FDA 510(k) clearance on 2016-12-01 under 510(k) 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. The listed applicant is Emed Technologies Corporation. The 510(k) number is K161906.

When did SCIg60 Infuser receive FDA 510(k) clearance?

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

Who is the listed applicant for SCIg60 Infuser?

The FDA 510(k) record lists Emed Technologies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCIg60 Infuser?

The FDA product code for SCIg60 Infuser is PKP.

Other records listing Emed Technologies Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251105Tetra (TM-20); Tetra (TM-50)K240148SCIg60 Infusion SystemK230883VersaPump Infusion SystemK213429AccuSert Needle InserterK222087SCIg60 Infusion SystemK173783SCIg60 Infusion System

View all 7 devices →

Related Devices (Code: PKP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251105Tetra (TM-20); Tetra (TM-50)Emed Technologies CorporationK240148SCIg60 Infusion SystemEmed Technologies CorporationK230883VersaPump Infusion SystemEmed Technologies CorporationK222087SCIg60 Infusion SystemEmed Technologies CorporationK173783SCIg60 Infusion SystemEmed 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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