Insulin Pump
FDA 510(k) K051041 · Abbott Diabetes Care, Inc.
510(k) numberK051041
Submission
- Device name
- Insulin Pump
- Applicant
- Abbott Diabetes Care, Inc.
Alameda, CA, US - Received
- April 25, 2005
- Decision date
- December 23, 2005
- 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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| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 01/08/2019SE |
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Questions and answers
When was Insulin Pump cleared by the FDA?
Insulin Pump (K051041) received a 510(k) decision of Substantially Equivalent on December 23, 2005, 242 days after the submission was received.
What is the product code of K051041?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.