Somanetics Invos 3100A Cerebral Oximeter (Invos)
FDA 510(k) K971628 · Somanetics Corp.
510(k) numberK971628
Submission
- Device name
- Somanetics Invos 3100A Cerebral Oximeter (Invos)
- Applicant
- Somanetics Corp.
Troy, MI, US - Received
- May 2, 1997
- Decision date
- October 10, 1997
- 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 |
|---|---|---|
| K093422 | Vital Sync Model 5000 SeriesMWI · Traditional | 04/29/2010SE |
| K091224 | Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: Is-C and Is-SMUD · Special | 07/09/2009SE |
| K082327 | Invos Cerebral/Somatic Oximeter System, Model: 5100CMUD · Traditional | 04/03/2009SE |
| K080769 | Invos Cerebral/Somatic Oximeter System, Model 5100CMUD · Traditional | 05/14/2008SE |
| K051274 | Invos SystemMUD · Traditional | 11/04/2005SE |
| K040162 | Correstore Patch SystemDXZ · Traditional | 03/16/2004SE |
| K031586 | Correstore Patch SystemDXZ · Traditional | 08/07/2003SE |
| K011487 | Correstore Patch, Models 1.5P2, 2P3, 3P4; Correstore Sizer, Model CRPSDXZ · Traditional | 11/21/2001SE |
| K001842 | Adult/Pediatric Cerebral Oximeter, Model Invos 5100DQA · Traditional | 09/15/2000SE |
| K960614 | Somanetics Invos 3100A Cerebral Oximeter (Invos)DQA · Traditional | 06/05/1996SE |
Questions and answers
When was Somanetics Invos 3100A Cerebral Oximeter (Invos) cleared by the FDA?
Somanetics Invos 3100A Cerebral Oximeter (Invos) (K971628) received a 510(k) decision of Substantially Equivalent on October 10, 1997, 161 days after the submission was received.
What is the product code of K971628?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.