Monitor, Carbon-Dioxide, Cutaneous
Monitor, Carbon-Dioxide, Cutaneous is a non-invasive monitoring device that measures carbon dioxide levels through the skin (transcutaneously), used to assess ventilation and respiratory status in patients requiring continuous gas exchange monitoring such as neonates or patients under sedation. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LKD, regulated under 21 CFR 868.2480, within the Anesthesiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LKD
- Device Class
- FDA class 2
- Regulation Number
- 868.2480
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232516 | Sentec Digital Monitoring System (SDMS) tCOM+ | May 17, 2024 | Substantially Equivalent | Sentec AG |
| K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet | Dec 17, 2015 | Substantially Equivalent | Sentec AG |
| K131253 | PERIFLUX 6000 | Oct 22, 2013 | Substantially Equivalent | Perimed AB |
| K110474 | PHILIPS INTELLIVUE TCG10 | Sep 30, 2011 | Substantially Equivalent | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN |
| K101690 | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE | Dec 03, 2010 | Substantially Equivalent | Sentec AG |
| K093154 | TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM | Feb 05, 2010 | Substantially Equivalent | Radiometer Medical Aps |
| K043357 | TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 | Mar 04, 2005 | Substantially Equivalent | Linde Medical Sensors AG |
| K043003 | TCM40 MONITORING SYSTEM | Mar 01, 2005 | Substantially Equivalent | Radiometer Medical Aps |
| K041548 | SENTEC DIGITAL MONITOR MODEL #SDM | Aug 09, 2004 | Substantially Equivalent | Sentec, Inc. |
| K990960 | PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) | Sep 23, 1999 | Substantially Equivalent | Perimed, Inc. |
| K980756 | COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE | Nov 05, 1998 | Substantially Equivalent | Ge Medical Systems Information Technologies |
| K913013 | TCPO2 9260 MODULE - SYSTEM ATHENA | May 03, 1994 | Substantially Equivalent | S & W Medico Teknik |
| K905225 | HBO CABLE ASSEMBLY, RADIOMETER TC-02 | Apr 10, 1991 | Substantially Equivalent | Sechrist |
| K900333 | E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT. | Apr 16, 1990 | Substantially Equivalent | Radiometer America, Inc. |
| K891481 | SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE | Sep 29, 1989 | Substantially Equivalent | Siemens Medical Electronics |
| K890517 | TRANSCUTANEOUS O2/CO2 MONITOR | Apr 14, 1989 | Substantially Equivalent | Novametrix Medical Systems, Inc. |
| K883606 | MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS | Dec 16, 1988 | Substantially Equivalent | Hewlett-Packard Co. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.