Oxiscan II Data Management System
FDA 510(k) K080348 · Airsep Corp.
510(k) numberK080348
Submission
- Device name
- Oxiscan II Data Management System
- Applicant
- Airsep Corp.
Buffalo, NY, US - Received
- February 11, 2008
- Decision date
- October 9, 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
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| 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 |
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| K012037 | Healthlife Oxygen Concentrator Model AS009CAW · Traditional | 01/17/2002SE |
| K000963 | Da Vinchi EEG and Emg/Ep SystemsGWF · Traditional | 10/20/2000SE |
| K001579 | Impulse SelectNFB · Traditional | 08/31/2000SE |
| K001467 | Da Vinchi Emg/Ep ISA1004EPGWE · Traditional | 08/01/2000SE |
| K001013 | Monet Acquisition System for EEG and PolysomnographyOLV · Traditional | 05/16/2000SE |
| K992283 | Artisan Acquisition System for EEG and PolysomnographyOLV · Traditional | 08/27/1999SE |
| K983002 | Mystique Ultrasonic NebulizerCAF · Traditional | 10/16/1998SE |
Questions and answers
When was Oxiscan II Data Management System cleared by the FDA?
Oxiscan II Data Management System (K080348) received a 510(k) decision of Substantially Equivalent on October 9, 2008, 241 days after the submission was received.
What is the product code of K080348?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.