510(k) K101690 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
| Applicant | Sentec AG, Egale WI, US |
| Decision | Substantially Equivalent, Dec 3, 2010 |
| Received | Jun 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101690
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2023 | SenTec AG Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package cont Open, Classified |
LKD | None listed |
| Dec 10, 2020 | SenTec AG SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure Terminated |
LKD | None listed |
| May 2, 2019 | SenTec AG SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse r Terminated |
LKD | None listed |
| May 2, 2019 | SenTec AG SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as Terminated |
LKD | None listed |
| May 2, 2019 | SenTec AG SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as Terminated |
LKD | None listed |
| May 2, 2019 | SenTec AG SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation an Terminated |
LKD | None listed |
| May 2, 2019 | SenTec AG SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in Terminated |
LKD | None listed |
| Oct 17, 2016 | SenTec AG SDMS (SenTec Digital Monitoring System) Terminated |
LKD | None listed |
| Apr 22, 2015 | SenTec AG Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital Monitoring System (SDMS) is used for continuous and non-invasi Terminated |
LKD | None listed |
| Nov 22, 2012 | Sentec AG SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only.
The V-sign Sensor is indicated for use with the SenTec Digital Terminated |
LKD | None listed |
| Nov 22, 2012 | Sentec AG SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only.
The V-sign Sensor is indicated for use Terminated |
LKD | None listed |
| Aug 13, 2012 | Sentec AG SenTec, V-Sign"2 Sensors
The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2). Terminated |
LKD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.