LKD — Monitor, Carbon-Dioxide, Cutaneous Class II
FDA product code LKD covers "Monitor, Carbon-Dioxide, Cutaneous", a Class II medical device regulated under 21 CFR 868.2480. Submissions are reviewed by the Anesthesiology panel. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LKD
- Device Class
- Class II
- Regulation Number
- 868.2480
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232516 | sentec | Sentec Digital Monitoring System (SDMS) tCOM+ | May 17, 2024 |
| K151329 | sentec | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V- | December 17, 2015 |
| K131253 | perimed | PERIFLUX 6000 | October 22, 2013 |
| K110474 | philips medizinsysteme boeblingen gmbh, cardiac an | PHILIPS INTELLIVUE TCG10 | September 30, 2011 |
| K101690 | sentec | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR AD | December 3, 2010 |
| K093154 | radiometer medical aps | TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM | February 5, 2010 |
| K043357 | linde medical sensors | TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 | March 4, 2005 |
| K043003 | radiometer medical aps | TCM40 MONITORING SYSTEM | March 1, 2005 |
| K041548 | sentec | SENTEC DIGITAL MONITOR MODEL #SDM | August 9, 2004 |
| K990960 | perimed | PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) | September 23, 1999 |
| K980756 | ge medical systems information technologies | COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE | November 5, 1998 |
| K913013 | s and w medico teknik | TCPO2 9260 MODULE - SYSTEM ATHENA | May 3, 1994 |
| K905225 | sechrist | HBO CABLE ASSEMBLY, RADIOMETER TC-02 | April 10, 1991 |
| K900333 | radiometer america | E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT. | April 16, 1990 |
| K891481 | siemens medical electronics | SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE | September 29, 1989 |
| K890517 | novametrix medical systems | TRANSCUTANEOUS O2/CO2 MONITOR | April 14, 1989 |
| K883606 | hewlett-packard | MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS | December 16, 1988 |