K071788 is an FDA 510(k) clearance for the AVIATOR INSULIN PUMP. This device is classified as a Pump, Infusion, Insulin (Class II - Special Controls, product code LZG).
Submitted by Abbott Diabetes Care, Inc. (Alameda, US). The FDA issued a Cleared decision on January 11, 2008, 193 days after receiving the submission on July 2, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K071788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2007 |
| Decision Date | January 11, 2008 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LZG — Pump, Infusion, Insulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |