Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories
FDA 510(k) K073249 · Solaris Medical Technology, Inc.
510(k) numberK073249
Submission
- Device name
- Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories
- Applicant
- Solaris Medical Technology, Inc.
Great Neck, NY, US - Received
- November 19, 2007
- Decision date
- July 25, 2008
- 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 |
|---|---|---|
| K100077 | Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103DQA · Traditional | 10/07/2010SE |
| K101972 | Solaris Reusable and Disposable Blood Pressure CuffsDXQ · Traditional | 07/22/2010SE |
| K092950 | Solaris Models NT1 and NT1A Handheld Pulse Oximeters with Sensor AccessoriesDQA · Special | 03/12/2010SE |
| K061931 | Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103…DQA · Traditional | 01/31/2007SE |
Questions and answers
When was Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories cleared by the FDA?
Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories (K073249) received a 510(k) decision of Substantially Equivalent on July 25, 2008, 249 days after the submission was received.
What is the product code of K073249?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.