Edentec Model 2000W System 700 Monitor
FDA 510(k) K901060 · Edentec Corp.
510(k) numberK901060
Submission
- Device name
- Edentec Model 2000W System 700 Monitor
- Applicant
- Edentec Corp.
Eden Prairie, MN, US - Received
- March 6, 1990
- Decision date
- May 15, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K953363 | Oxiflow Digital RecorderBZQ · Traditional | 02/06/1996ST |
| K953540 | EeeBYD · Traditional | 08/25/1995SE |
| K921819 | Edentec Model 3710 I Digital PrinterBZQ · Traditional | 10/22/1993SE |
| K913749 | Edentrace Airflow 3171/SLEEP Lab Airflow 3170BZQ · Traditional | 07/02/1992SE |
| K910871 | Edentec Digital Charter Model 3710DSF · Traditional | 08/29/1991SE |
| K910870 | Edentec Model 3711 Digital RecorderDRT · Traditional | 08/29/1991SE |
| K905575 | Modified Models 2000W and 2000W Option H Apnea MonBZQ · Traditional | 06/20/1991SE |
| K893561 | Edentrace 670 System Multichannel Recorder W/Oxim.DSF · Traditional | 08/25/1989SE |
| K892227 | Edentec Model 2001 Modular Memory Unit (Mmu)DSH · Traditional | 06/20/1989SE |
| K891540 | Edentec Model 2860 Pressure MeterBYE · Traditional | 06/01/1989SE |
Questions and answers
When was Edentec Model 2000W System 700 Monitor cleared by the FDA?
Edentec Model 2000W System 700 Monitor (K901060) received a 510(k) decision of Substantially Equivalent on May 15, 1990, 70 days after the submission was received.
What is the product code of K901060?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.