Envitec Reusable SPO2 Sensors Type Nihon-Kohden
FDA 510(k) K102270 · Envitec-Wismar GmbH
510(k) numberK102270
Submission
- Device name
- Envitec Reusable SPO2 Sensors Type Nihon-Kohden
- Applicant
- Envitec-Wismar GmbH
Egale, WI, US - Received
- August 10, 2010
- Decision date
- February 22, 2011
- 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 |
|---|---|---|
| K133064 | Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger…DQA · Traditional | 05/02/2014SE |
| K122290 | Envitec Mysign O Oxygen Measuring DeviceCCL · Traditional | 01/23/2013SE |
| K090438 | Reusable Envitec Finger SPO2 Sensor-Hp/Philips Compatible, Models F-2412, F-2414-15…DQA · Traditional | 07/24/2009SE |
| K082655 | Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106CCL · Traditional | 11/25/2008SE |
| K070193 | Envitec Oxipen Pulse Oximeter and AccessoriesDQA · Traditional | 05/02/2007SE |
| K060675 | Envitec Reusable Softip Y SPO2 SensorsDQA · Special | 07/17/2006SE |
| K043463 | Envitec Reusable Multi-Site Y SPO2 SensorsDQA · Traditional | 02/11/2005SE |
| K992215 | Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult Disposable…DQA · Traditional | 03/29/2000SE |
Questions and answers
When was Envitec Reusable SPO2 Sensors Type Nihon-Kohden cleared by the FDA?
Envitec Reusable SPO2 Sensors Type Nihon-Kohden (K102270) received a 510(k) decision of Substantially Equivalent on February 22, 2011, 196 days after the submission was received.
What is the product code of K102270?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.