Compal Electronics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252078 | BreathePal Bilevel (GFM50-MD2201) | March 17, 2026 |
| K223135 | AblatePal Radiofrequency Ablation System | June 30, 2023 |
| K202074 | Apache Ultrasound System (Model C62) | November 12, 2020 |