SCIg60 Infuser, Infuset— 510(k) K142319

Name: FDA 510(k) clearance K142319
Creator: U.S. Food and Drug Administration
Published: 2015-05-14

Substantially Equivalent

Emed Technologies Corporation

FDA 510(k) clearance K142319 for SCIg60 Infuser, Infuset, Substantially Equivalent on 2015-05-14. 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: 2014-08-20
Decision date: 2015-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado Hills, CA, US

Download summary PDF View on FDA.gov ↗

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K173783 — SCIg60 Infusion System2018-12-14

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K213429 — AccuSert Needle Inserter2022-10-20
K161906 — SCIg60 Infuser2016-12-01
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.