Symphony Meter Remote
FDA 510(k) K082590 · Lifescan, Inc.
510(k) numberK082590
Submission
- Device name
- Symphony Meter Remote
- Applicant
- Lifescan, Inc.
Milpitas, CA, US - Received
- September 8, 2008
- Decision date
- December 17, 2008
- 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
Other 510(k)s with product code LZG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262153 | Pivot Insulin Delivery SystemLZG · Traditional | Modular Medical, Inc. | 09/02/2026SE |
| K253534 | Pivot Insulin Delivery SystemLZG · Traditional | Modular Medical | 04/08/2026SE |
| K240158 | Modular Medical MODD1 Insulin Delivery SystemLZG · Traditional | Modular Medical, Inc. | 09/04/2024SE |
| 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 |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 10/21/2019SE |
| 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 |
|---|---|---|
| K132618 | Onetouch RevealMRZ · Traditional | 12/16/2013SE |
| K120558 | Onetouch Reveal Diabetes Management ApplicationNBW · Traditional | 02/07/2013SE |
| K093745 | One Touch Verio Blood Glucose Monitoring SystemNBW · Traditional | 02/11/2011SE |
| K082513 | Onetouch Vita Blood Glucose Monitoring SystemNBW · Special | 10/22/2008SE |
| K081318 | Onetouch Zoom Diabetes Management ProgramNBW · Special | 06/09/2008SE |
| K073231 | Onetouch Ultralink Blood Glucose Monitoring SystemNBW · Traditional | 04/18/2008SE |
| K072543 | Onetouch Select Blood Glucose Monitoring SystemNBW · Special | 10/05/2007SE |
| K062195 | Modification to One Touch Ultra Blood Glucose Monitoring SystemNBW · Special | 08/16/2006SE |
| K061118 | Onetouch Ultramini Blood Glucose Monitoring SystemNBW · Special | 05/19/2006SE |
| K053529 | Onetouch Ultra 2 Blood Glucose Monitoring SystemNBW · Special | 01/17/2006SE |
Questions and answers
When was Symphony Meter Remote cleared by the FDA?
Symphony Meter Remote (K082590) received a 510(k) decision of Substantially Equivalent on December 17, 2008, 100 days after the submission was received.
What is the product code of K082590?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.