510(k) K243273
K243273 is an FDA 510(k) premarket notification submitted by Cequr SA for the device "CeQur Simplicity On-Demand Insulin Delivery System". The FDA issued a decision of Substantially Equivalent on Nov 13, 2024. The device falls under product code OPP (Pump, Infusion, Insulin Bolus), a Class II device regulated under 21 CFR 880.5725. Cequr SA has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 13, 2024
- Date Received
- Oct 16, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Insulin Bolus
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- CH
- Submission Type
The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.