Panels › Anesthesiology › Product code LKD · Class 2
Monitor, Carbon-Dioxide, Cutaneous
Regulation 868.2480
0510(k)s in 12 months (17 all time)
0recalls in 12 months (23 all time)
23recalls that name a 510(k)
Top companies in LKD
| Company | 510(k)s | Recalls |
|---|---|---|
| Sentec AG | 4 | 14 |
| Philips Healthcare Inc. | 0 | 4 |
| Radiometer America, Inc. | 1 | 3 |
| Radiometer Medical Aps | 2 | 1 |
| Perimed AB | 2 | 0 |
| Ge Medical Systems Information Technologies | 1 | 0 |
| Hewlett-Packard Co. | 1 | 0 |
| Linde Medical Sensors AG | 1 | 0 |
| Novametrix Medical Systems, Inc. | 1 | 0 |
| Philips Medical Systems, Inc. | 0 | 1 |
| 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 | K041548 K101690 +1 |
| Jun 20, 2023 | SenTec AG V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS). Open, Classified |
LKD | K041548 |
| Oct 28, 2022 | SenTec AG sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring. Terminated |
LKD | K151329 |
| 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 | K041548 K101690 +1 |
| Feb 20, 2020 | Radiometer Medical ApS TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Terminated |
LKD | K001866 K043003 +1 |
| 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 | K041548 K101690 +1 |
| 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 | K041548 K101690 +1 |
| 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 | K041548 K101690 +1 |
| 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 | K041548 K101690 +1 |
| 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 | K041548 K101690 +1 |
| Oct 17, 2016 | SenTec AG SDMS (SenTec Digital Monitoring System) Terminated |
LKD | K041548 K071672 +2 |
| Nov 18, 2015 | Radiometer America Inc TCM CombiM
Modules 903-111 Terminated |
LKD | K093154 |
| Aug 19, 2015 | Radiometer America Inc Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are Terminated |
LKD | K093154 |
| 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 | K101690 |
| Jan 16, 2015 | Philips Medical Systems, Inc. Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous.
The IntelliVue TcG10 is a device for the measurement of the transcutaneous O2 and CO2 partial pressure in neonates, pediatrics and adults Terminated |
LKD | K110474 |
| 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 | K101690 |
| 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 | K101690 |
| 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 | K101690 |
| Dec 1, 2011 | Radiometer America Inc TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003.
Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive devi Terminated |
LKD | K043003 |
| Apr 8, 2010 | Philips Healthcare Inc. Transcutaneous C02 & 02 Monitor - 860, Refurbished, Respironics/Philips product.
Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 Terminated |
LKD | K890517 |
| Apr 8, 2010 | Philips Healthcare Inc. Spanish 100-120V TCOM-860, Respironics/Philips product.
Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurements. Terminated |
LKD | K890517 |
| Apr 8, 2010 | Philips Healthcare Inc. French 100-120V 860 TC C02 & 02 Monitor, Respironics/Philips product.
Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurement Terminated |
LKD | K890517 |
| Apr 8, 2010 | Philips Healthcare Inc. Transcutaneous C02 & O2 Monitor - 860, Respironics/Philips product.
Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurements. Terminated |
LKD | K890517 |
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