Submission Details
| 510(k) Number | K071788 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
AVIATOR INSULIN PUMP
Jan 2008
Decision
193d
Days
Class 2
Risk
About This 510(k) Submission
K071788 is an FDA 510(k) clearance for the AVIATOR INSULIN PUMP, 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 review panel. Regulated under 21 CFR 880.5725.
Device Classification
| Product Code | LZG — Pump, Infusion, Insulin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5725 |
Manufacturer
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