FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000— 510(k) K100947

Name: FDA 510(k) clearance K100947
Creator: U.S. Food and Drug Administration
Published: 2010-06-28

Substantially Equivalent

Calibra Medical, Inc.

FDA 510(k) clearance K100947 for FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000, Substantially Equivalent on 2010-06-28. Applicant: Calibra Medical, Inc.. Device class: 2.

Clearance details

Applicant: Calibra Medical, Inc.
Product code: Code OPP
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2010-04-06
Decision date: 2010-06-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OPP

view all

K252757 — CeQur Simplicity On-Demand Insulin Delivery System2026-04-10
K243273 — CeQur Simplicity On-Demand Insulin Delivery System2024-11-13
K233447 — CeQur Simplicity On-Demand Insulin Delivery System2024-01-18
K163357 — OneTouch Via On-Demand Insulin Delivery System2017-06-07
K111924 — FINESSE PERSONAL INSULIN DELIVERY PATCH2012-04-10

More clearances from Calibra Medical, Inc.

view all

K093065 — FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-20002010-01-20

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