Product code LPP
- Device name
- Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.2500
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07640121881015 | 103421 Sensor Adapter Cable (Long) | SenTec AG | 2024-07-05 |
| 07640121881008 | 103420 Sensor Adapter Cable (Regular) | SenTec AG | 2024-07-05 |
| 07640121880995 | 103164 tCOM+ | SenTec AG | 2024-07-05 |
| 07640121880988 | 103149 Calibration Gas | SenTec AG | 2024-07-05 |
| 07640121880971 | Patient Application Kit for sensitive/fragile skin | SenTec AG | 2021-09-26 |
| 07640121880964 | Patient Application Kit for mature intact skin | SenTec AG | 2021-09-26 |
| 07640121880957 | Patient Application Kit with Ear Clip for mature/intact skin | SenTec AG | 2021-09-26 |
| 07640121880933 | Membrane Changer (single-use) / single unit | SenTec AG | 2021-02-28 |
| 07640121880810 | Ear Clip easy | SenTec AG | 2020-03-31 |
| 07640121880803 | Multi-Site Attachment Ring for fragile/sensitive skin | SenTec AG | 2019-01-29 |
| 07640121880513 | V-Sign™ Sensor 2 | SenTec AG | 2016-08-31 |
| 07640121880773 | V-STATS™ Installation CD | SenTec AG | 2016-08-31 |
| 07640121880759 | SenTec Digital Monitor (with activated PO2 channel) | SenTec AG | 2016-08-31 |
| 07640121880742 | OxiVenT™ Sensor | SenTec AG | 2016-08-31 |
| 07640121880568 | Staysite Adhesive | SenTec AG | 2016-08-31 |
| 07640121880018 | Sentec Digital Monitor | SenTec AG | 2016-08-31 |
| 07640121880506 | Membrane Changer Inserts | SenTec AG | 2016-08-31 |
| 07640121880490 | Membrane Changer Set | SenTec AG | 2016-08-31 |
| 07640121880445 | Neonatal Starter Set (without Service Gas) | SenTec AG | 2016-08-31 |
| 07640121880438 | Neonatal Starter Set | SenTec AG | 2016-08-31 |
| 07640121880308 | Standard Starter Set (without Service Gas) | SenTec AG | 2016-08-31 |
| 07640121880230 | Multi-Site Attachment Ring for fragile/sensitive skin | SenTec AG | 2016-08-31 |
| 07640121880223 | Multi-Site Attachment Ring for mature/intact skin | SenTec AG | 2016-08-31 |
| 07640121880179 | Digital Sensor Adapter Cable, 750 cm | SenTec AG | 2016-08-31 |
| 07640121880162 | Digital Sensor Adapter Cable, 250 cm | SenTec AG | 2016-08-31 |
| 07640121880087 | Membrane Changer (reloadable) / single unit | SenTec AG | 2016-08-31 |
| 07640121880070 | Contact Gel | SenTec AG | 2016-08-31 |
| 07640121880056 | Service gas | SenTec AG | 2016-08-31 |
| 07640121880049 | Ear Clip | SenTec AG | 2016-08-31 |
| 07640121880032 | Digital Sensor Adapter Cable, 150 cm | SenTec AG | 2016-08-31 |