Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
FDA 510(k) K233963 · Taiwan Aulisa Medical Devices Technologies, Inc.
510(k) numberK233963
Submission
- Device name
- Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
- Applicant
- Taiwan Aulisa Medical Devices Technologies, Inc.
Taipei City, TW - Received
- December 15, 2023
- Decision date
- February 25, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQA – Oximeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
Other 510(k)s with product code DQA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)…DQA · Traditional | Philips Medizin Systeme Böblingen GmbH | 05/29/2026SE |
| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO…DQA · Traditional | Shenzhen Imdk Medical Technology Co., Ltd. | 05/11/2026SE |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…DQA · Traditional | Philips Medizin Systeme | 05/01/2026SE |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)DQA · Special | Unimed Medical Supplies, Inc. | 04/14/2026SE |
| K252448 | AViTA Pulse Oximeter (SP61)DQA · Traditional | Avita Corporation | 02/27/2026SE |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)DQA · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 02/17/2026SE |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)DQA · Traditional | Shenzhen Best Electronics Co., Ltd. | 01/07/2026SE |
| K251751 | Spo2 Sensor CSS032DDQA · Traditional | Shenzhen Ykd Technology Co., Ltd. | 12/19/2025SE |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
More from Unimed Medical Supplies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233956 | Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)DQA · Traditional | 01/30/2025SE |
| K240220 | Aulisa Temperature Module (TM0002)FLL · Traditional | 09/27/2024SE |
| K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemDQA · Traditional | 06/12/2022SE |
| K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring SystemMSX · Traditional | 10/30/2020SE |
| K191207 | Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemDQA · Special | 06/25/2019SE |
| K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemDQA · Traditional | 03/01/2019SE |
| K182822 | Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemDQA · Traditional | 03/01/2019SE |
| K162580 | Guardian Angel GA1000 Digital Vital Sign Monitoring SystemDQA · Traditional | 03/03/2017SE |
Questions and answers
When was Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) cleared by the FDA?
Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) (K233963) received a 510(k) decision of Substantially Equivalent on February 25, 2025, 438 days after the submission was received.
What is the product code of K233963?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.