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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 17, 2024 | K232516 | Sentec Digital Monitoring System (SDMS) tCOM+ Sentec AG, CH | LKD |
| Dec 17, 2015 | K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet Sentec AG, CH | LKD |
| Oct 22, 2013 | K131253 | PERIFLUX 6000 Perimed AB, SE | LKD |
| Sep 30, 2011 | K110474 | PHILIPS INTELLIVUE TCG10 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE | LKD |
| Dec 3, 2010 | K101690 | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE Sentec AG | LKD |
| Feb 5, 2010 | K093154 | TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM Radiometer Medical Aps, DK | LKD |
| Mar 4, 2005 | K043357 | TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 Linde Medical Sensors AG, CH | LKD |
| Mar 1, 2005 | K043003 | TCM40 MONITORING SYSTEM Radiometer Medical Aps, DK | LKD |
| Aug 9, 2004 | K041548 | SENTEC DIGITAL MONITOR MODEL #SDM Sentec, Inc. | LKD |
| Sep 23, 1999 | K990960 | PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) Perimed, Inc. | LKD |
| Nov 5, 1998 | K980756 | COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE Ge Medical Systems Information Technologies | LKD |
| May 3, 1994 | K913013 | TCPO2 9260 MODULE - SYSTEM ATHENA S & W Medico Teknik, DK | LKD |
| Apr 10, 1991 | K905225 | HBO CABLE ASSEMBLY, RADIOMETER TC-02 Sechrist | LKD |
| Apr 16, 1990 | K900333 | E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT. Radiometer America, Inc. | LKD |
| Sep 29, 1989 | K891481 | SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE Siemens Medical Electronics | LKD |
| Apr 14, 1989 | K890517 | TRANSCUTANEOUS O2/CO2 MONITOR Novametrix Medical Systems, Inc. | LKD |
| Dec 16, 1988 | K883606 | MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS Hewlett-Packard Co. | LKD |
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