510(k) K122953
K122953 is an FDA 510(k) premarket notification submitted by Insulet Corporation for the device "OMNIPOD INSULIN MANAGMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on Dec 7, 2012. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Insulet Corporation has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 7, 2012
- Date Received
- Sep 25, 2012
- 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
- 510(k)