FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
CeQur Simplicity On-Demand Insulin Delivery System
K Number: K243273
·
Decision Nov 13, 2024
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
5
Applicant Total
2
Review Days
28
Basic Information
- Device Name
- CeQur Simplicity On-Demand Insulin Delivery System
- K Number
- K243273
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CeQur SA
- Date Received
- October 16, 2024
- Decision Date
- November 13, 2024
- Product Code
- OPP
- Advisory Committee
- General Hospital
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OPP | Pump, Infusion, Insulin Bolus | FDA class 2 | General Hospital |
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Other Clearances by CeQur SA
| K Number | Device Name | ||
|---|---|---|---|
| K233447 | CeQur Simplicity On-Demand Insulin Delivery System | Jan 18, 2024 | Substantially Equivalent |