Modification to MARSPO2, Model 2001
FDA 510(k) K000794 · Novametrix Medical Systems, Inc.
510(k) numberK000794
Submission
- Device name
- Modification to MARSPO2, Model 2001
- Applicant
- Novametrix Medical Systems, Inc.
Wallingford, CT, US - Received
- March 13, 2000
- Decision date
- April 10, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K010451 | Novametrix Marquette Compatible SensorsDQA · Abbreviated | 04/25/2001SE |
| K993979 | MARSPO2, Model 2001DQA · Abbreviated | 02/22/2000SE |
| K982499 | Cosmo Plus with Nico, Model 8200BZC · Traditional | 10/16/1998SE |
| K964360 | Vent(Ventcheck) Handheld Respiratory/Mechanics Monitor Model 101BZC · Traditional | 04/04/1997SE |
| K963380 | Co 2 Smo PlusBZC · Traditional | 01/22/1997SE |
| K963327 | Tidal Wave Carbon Dioxide Monitor, Model 610CCK · Traditional | 11/20/1996SE |
| K960831 | Ventrak RMMS 1550BZC · Traditional | 05/29/1996SE |
| K924626 | Novametrix Model 510DQA · Traditional | 12/03/1993SE |
| K920379 | Novametrix Model 7100 Comb. End Tidal CO2 & Pul OxDQA · Traditional | 07/15/1992SE |
| K913516 | Model 520A Novametrix Pulse OximeterDQA · Traditional | 11/04/1991SE |
Questions and answers
When was Modification to MARSPO2, Model 2001 cleared by the FDA?
Modification to MARSPO2, Model 2001 (K000794) received a 510(k) decision of Substantially Equivalent on April 10, 2000, 28 days after the submission was received.
What is the product code of K000794?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.