1298960
Expanse Medical Inc. — FEI 3017823876
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 15, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pleasanton, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |