Ezmanager Max Diabetes Management Software
FDA 510(k) K063674 · Animas Corp.
510(k) numberK063674
Submission
- Device name
- Ezmanager Max Diabetes Management Software
- Applicant
- Animas Corp.
West Chester, PA, US - Received
- December 11, 2006
- Decision date
- March 30, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K241622 | Extended Reservoir; MiniMed ReservoirLZG · Special | Medtronic Minimed | 07/02/2024SE |
| K223372 | Omnipod GO Insulin Delivery DeviceLZG · Traditional | Insulet Corporation | 04/24/2023SE |
| K210714 | Extended ReservoirLZG · Traditional | Medtronic Minimed, Inc. | 04/06/2022SE |
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemLZG · Traditional | Insulet Corporation | 08/13/2021SE |
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| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 01/08/2019SE |
| K180045 | Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 06/01/2018SE |
More from Insulet Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K080639 | Symphony Glucose Management SystemLZG · Traditional | 06/24/2008SE |
| K080587 | Ez Manager Max Diabetes Management SoftwareMRZ · Traditional | 05/15/2008SE |
| K042873 | Animas Model IR1250 Insulin Infusion PumpLZG · Traditional | 12/10/2004SE |
| K032257 | Model Ir 1200 Insulin PumpLZG · Traditional | 10/16/2003SE |
| K022394 | Ezmanager PlusLZG · Traditional | 06/05/2003SE |
| K021700 | Animus Ezserter Infusion Set InserterKZH · Traditional | 06/04/2002SE |
| K021439 | Model R1000 Ir Insulin Pump, Ezlink Software, Sermon Software, R1000 Ir Download Cradle…LZG · Special | 05/29/2002SE |
| K012754 | Ez Set Infusion SetFPA · Traditional | 08/27/2001SE |
| K993184 | R1000 Series Insulin PumpLZG · Traditional | 02/10/2000SE |
Questions and answers
When was Ezmanager Max Diabetes Management Software cleared by the FDA?
Ezmanager Max Diabetes Management Software (K063674) received a 510(k) decision of Substantially Equivalent on March 30, 2007, 109 days after the submission was received.
What is the product code of K063674?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.