SCIg60 Infuser— 510(k) K161906

Substantially Equivalent

Emed Technologies Corporation

FDA 510(k) clearance K161906 for SCIg60 Infuser, Substantially Equivalent on 2016-12-01. 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: 2016-07-12
Decision date: 2016-12-01
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

K251105 — Tetra (TM-20); Tetra (TM-50)2025-12-22
K240148 — SCIg60 Infusion System2024-02-16
K230883 — VersaPump Infusion System2023-11-28
K222087 — SCIg60 Infusion System2022-10-13
K173783 — SCIg60 Infusion System2018-12-14

More clearances from Emed Technologies Corporation

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.