ClearanceBrief
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)
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Top companies in LKD

DateFirm and productCodeLinked 510(k)
Sep 15, 2023SenTec 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
LKDK041548
K101690 +1
Jun 20, 2023SenTec AG
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Open, Classified
LKDK041548
Oct 28, 2022SenTec 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
LKDK151329
Dec 10, 2020SenTec 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
LKDK041548
K101690 +1
Feb 20, 2020Radiometer 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
LKDK001866
K043003 +1
May 2, 2019SenTec 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
LKDK041548
K101690 +1
May 2, 2019SenTec 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
LKDK041548
K101690 +1
May 2, 2019SenTec 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
LKDK041548
K101690 +1
May 2, 2019SenTec 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
LKDK041548
K101690 +1
May 2, 2019SenTec 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
LKDK041548
K101690 +1
Oct 17, 2016SenTec AG
SDMS (SenTec Digital Monitoring System)
Terminated
LKDK041548
K071672 +2
Nov 18, 2015Radiometer America Inc
TCM CombiM Modules 903-111
Terminated
LKDK093154
Aug 19, 2015Radiometer 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
LKDK093154
Apr 22, 2015SenTec 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
LKDK101690
Jan 16, 2015Philips 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
LKDK110474
Nov 22, 2012Sentec 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
LKDK101690
Nov 22, 2012Sentec 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
LKDK101690
Aug 13, 2012Sentec 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
LKDK101690
Dec 1, 2011Radiometer 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
LKDK043003
Apr 8, 2010Philips 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
LKDK890517
Apr 8, 2010Philips 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
LKDK890517
Apr 8, 2010Philips 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
LKDK890517
Apr 8, 2010Philips 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
LKDK890517

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