SCIg60 Infusion System— 510(k) K222087

Name: FDA 510(k) clearance K222087
Creator: U.S. Food and Drug Administration
Published: 2022-10-13

Substantially Equivalent

Emed Technologies Corporation

FDA 510(k) clearance K222087 for SCIg60 Infusion System, Substantially Equivalent on 2022-10-13. Applicant: Emed Technologies Corporation. Device class: 2.

Clearance details

Applicant: Emed Technologies Corporation
Product code: Code PKP
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2022-07-15
Decision date: 2022-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado Hills, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PKP

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K251105 — Tetra (TM-20); Tetra (TM-50)2025-12-22
K240148 — SCIg60 Infusion System2024-02-16
K230883 — VersaPump Infusion System2023-11-28
K173783 — SCIg60 Infusion System2018-12-14
K161906 — SCIg60 Infuser2016-12-01

More clearances from Emed Technologies Corporation

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K213429 — AccuSert Needle Inserter2022-10-20
K142319 — SCIg60 Infuser, Infuset2015-05-14
K140133 — INFUSET FLOW CONTROL EXTENSION SET2014-05-15
K140131 — SUB-Q SUBCUTANEOUS TISSUE INFUSION SET2014-04-03
K123729 — VERSARATE FLOW RATE CONTROLER2012-12-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.