510(k) K162296
K162296 is an FDA 510(k) premarket notification submitted by Insulet Corporation for the device "OmniPod Insulin Management System". The FDA issued a decision of Substantially Equivalent on April 18, 2017. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Insulet Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 2017
- Date Received
- August 16, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Insulin
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- CH
- Submission Type