Aviator Insulin Pump
FDA 510(k) K071788 · Abbott Diabetes Care, Inc.
510(k) numberK071788
Submission
- Device name
- Aviator Insulin Pump
- Applicant
- Abbott Diabetes Care, Inc.
Alameda, CA, US - Received
- July 2, 2007
- Decision date
- January 11, 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
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Questions and answers
When was Aviator Insulin Pump cleared by the FDA?
Aviator Insulin Pump (K071788) received a 510(k) decision of Substantially Equivalent on January 11, 2008, 193 days after the submission was received.
What is the product code of K071788?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.