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Taiwan Aulisa Medical Devices Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 9
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233963 | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | February 25, 2025 |
| K233956 | Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) | January 30, 2025 |
| K240220 | Aulisa Temperature Module (TM0002) | September 27, 2024 |
| K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System | June 12, 2022 |
| K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring System | October 30, 2020 |
| K191207 | Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System | June 25, 2019 |
| K182822 | Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System | March 1, 2019 |
| K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System | March 1, 2019 |
| K162580 | Guardian Angel GA1000 Digital Vital Sign Monitoring System | March 3, 2017 |