FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
CeQur Simplicity On-Demand Insulin Delivery System
K Number: K233447
·
Decision Jan 18, 2024
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
6
Applicant Total
3
Review Days
91
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Basic Information
- Device Name
- CeQur Simplicity On-Demand Insulin Delivery System
- K Number
- K233447
- 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 19, 2023
- Decision Date
- January 18, 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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