SmartPilot YpsoMate NS-A2.25
FDA 510(k) clearance K243901 · decided 2025-08-28
Clearance details
- K-number
- K243901
- Device name
- SmartPilot YpsoMate NS-A2.25
- Applicant
- Ypsomed AG
- Decision
- Substantially Equivalent
- Date received
- 2024-12-19
- Decision date
- 2025-08-28
- Days to decision
- 252 days
- Clearance type
- Traditional
- Product code
- QOG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Burgdorf, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.