CeQur Simplicity On-Demand Insulin Delivery System— 510(k) K233447

Name: FDA 510(k) clearance K233447
Creator: U.S. Food and Drug Administration
Published: 2024-01-18

Substantially Equivalent

Cequr SA

FDA 510(k) clearance K233447 for CeQur Simplicity On-Demand Insulin Delivery System, Substantially Equivalent on 2024-01-18. Applicant: Cequr SA. Device class: 2.

Clearance details

Applicant: Cequr SA
Product code: Code OPP
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2023-10-19
Decision date: 2024-01-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Horw Luzern, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code OPP

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K252757 — CeQur Simplicity On-Demand Insulin Delivery System2026-04-10
K243273 — CeQur Simplicity On-Demand Insulin Delivery System2024-11-13
K163357 — OneTouch Via On-Demand Insulin Delivery System2017-06-07
K111924 — FINESSE PERSONAL INSULIN DELIVERY PATCH2012-04-10
K100947 — FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 20002010-06-28

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