FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
twiist system
K Number: K250930
·
Decision Apr 2, 2025
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
20
Applicant Total
3
Review Days
5
Basic Information
- Device Name
- twiist system
- K Number
- K250930
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5730
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DEKA Research & Development Corp.
- Date Received
- March 28, 2025
- Decision Date
- April 2, 2025
- Product Code
- QFG
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| QFG | Alternate Controller Enabled Insulin Infusion Pump | FDA class 2 | Clinical Chemistry |
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