Med-Link Temp-pulse Oximeter
FDA 510(k) K202743 · Shenzhen Med-Link Electronics Tech Co., Ltd.
510(k) numberK202743
Submission
- Device name
- Med-Link Temp-pulse Oximeter
- Applicant
- Shenzhen Med-Link Electronics Tech Co., Ltd.
Shenzhen, CN - Received
- September 18, 2020
- Decision date
- March 1, 2021
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS…FLL · Traditional | 01/08/2026SE |
| K220448 | Disposable Non-invasive EEG SensorGXY · Traditional | 01/19/2023SE |
| K220447 | Med-link Disposable ECG Cable and LeadwiresDSA · Traditional | 06/28/2022SE |
| K212752 | Med-link Pulse OximeterDQA · Traditional | 05/20/2022SE |
| K210441 | Incontinence ProbeKPI · Traditional | 09/17/2021SE |
| K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature ProbesFLL · Traditional | 08/25/2020SE |
| K181154 | Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure…DXN · Traditional | 08/02/2019SE |
| K182667 | Med-link Temperature ProbesFLL · Traditional | 06/18/2019SE |
| K173869 | Med-link Reusable Blood Pressure CuffDXQ · Traditional | 08/02/2018SE |
| K160530 | Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure CuffDXQ · Traditional | 11/28/2016SE |
Questions and answers
When was Med-Link Temp-pulse Oximeter cleared by the FDA?
Med-Link Temp-pulse Oximeter (K202743) received a 510(k) decision of Substantially Equivalent on March 1, 2021, 164 days after the submission was received.
What is the product code of K202743?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.