Dana Diabecare Iis

FDA 510(k) K063126 · Sooil Development Co., Ltd.

Substantially Equivalent

510(k) numberK063126

Submission

Device name
Dana Diabecare Iis
Applicant
Sooil Development Co., Ltd.
San Diego, CA, US
Received
October 13, 2006
Decision date
February 2, 2007
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LZG – Pump, Infusion, Insulin
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

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K223372Omnipod GO Insulin Delivery DeviceLZG · Traditional Insulet Corporation04/24/2023SE
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K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional Insulet Corporation10/21/2019SE
K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional Insulet Corporation01/08/2019SE
K180045Omnipod DASH Insulin Management SystemLZG · Traditional Insulet Corporation06/01/2018SE

More from Insulet Corporation

510(k)DeviceDecision
K071418Dana 3CC Syringe Insulin ReservoirMRZ · Traditional 09/04/2007SE
K022317Dana Diabecare II Insulin Pump & Superline-Easyrelease, Soft-Release-St, &…LZG · Special 08/02/2002SE
K001604Dana DiabecareLZG · Traditional 08/14/2000SE

Questions and answers

When was Dana Diabecare Iis cleared by the FDA?

Dana Diabecare Iis (K063126) received a 510(k) decision of Substantially Equivalent on February 2, 2007, 112 days after the submission was received.

What is the product code of K063126?

The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.