Disposable SpO2 Sensor
FDA 510(k) K200069 · Shenzhen Changke Connect Electronics Co., Ltd.
510(k) numberK200069
Submission
- Device name
- Disposable SpO2 Sensor
- Applicant
- Shenzhen Changke Connect Electronics Co., Ltd.
Shenzhen, CN - Received
- January 13, 2020
- Decision date
- March 13, 2020
- 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 |
|---|---|---|
| K213884 | Disposable EEG cableGXY · Abbreviated | 05/06/2022SE |
| K193625 | Disposable Temperature ProbeFLL · Traditional | 07/24/2020SE |
| K200026 | Disposable ECG CableDSA · Traditional | 05/12/2020SE |
| K193629 | Disposable NIBP CuffDXQ · Traditional | 03/25/2020SE |
| K191428 | ECG CableDSA · Traditional | 11/27/2019SE |
| K191420 | Reusable SpO2 SensorDQA · Traditional | 10/11/2019SE |
| K191253 | Reusable NIBP CuffDXQ · Traditional | 09/17/2019SE |
Questions and answers
When was Disposable SpO2 Sensor cleared by the FDA?
Disposable SpO2 Sensor (K200069) received a 510(k) decision of Substantially Equivalent on March 13, 2020, 60 days after the submission was received.
What is the product code of K200069?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.