Product code LKD
- Device name
- Monitor, Carbon-Dioxide, Cutaneous
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.2480
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P810037S010 | KONTRON KOLORMON PLUS BLOODGAS MODULE 7267505 | Kontron Cardiovascular | 1998-05-22 |
| P810037S007 | KONTRON CUTANEOUS PCO2 MONITOR | Kontron Cardiovascular | 1997-11-25 |
| P830008S003 | CUTANIOUS GAS MONITOR | Sensor Medics Corp. | 1988-02-29 |
| P810022S014 | TCO2M MODEL 818 MONITOR | Novametrix Medical Systems, Inc. | 1987-10-09 |
| P810022S013 | TCO2M MODEL 818 MONITOR | Novametrix Medical Systems, Inc. | 1987-01-29 |
| P840037S001 | MODEL 515 NEONATAL MONIOTR | Ge Medical Systems Information Technologies | 1986-11-19 |
| P850087S001 | LITTON TRANSCUTANEOUS CO2 SYSTEM | Litton Datamedix | 1986-11-14 |
| P810022S012 | TCO2M MODEL 818 MONITOR | Novametrix Medical Systems, Inc. | 1986-06-05 |
| P820019S007 | LIFESPAN(TM) 100 TCPCO2 MONITOR | Biochem International, Inc. | 1986-03-03 |
| P800043S004 | RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO | Radiometer America, Inc. | 1986-02-21 |
| P820019S006 | LIFESPAN(TM) 100 TCPCO2 MONITOR | Biochem International, Inc. | 1986-01-27 |
| P810022S011 | TCO2M MODEL 818 MONITOR | Novametrix Medical Systems, Inc. | 1985-11-21 |
| P820019S005 | LIFESPAN(TM) 100 TCPCO2 MONITOR | Biochem International, Inc. | 1985-11-19 |
| P810037S006 | KONTRON CUTANEOUS PCO2 MONITOR | Kontron Cardiovascular | 1985-09-12 |
| P810037S004 | KONTRON CUTANEOUS PCO2 MONITOR | Kontron Cardiovascular | 1985-09-12 |
| P810022S009 | TCO2M MODEL 818 MONITOR | Novametrix Medical Systems, Inc. | 1985-09-03 |
| P810037S005 | KONTRON CUTANEOUS PCO2 MONITOR | Kontron Cardiovascular | 1985-08-22 |
| P820019S003 | LIFESPAN(TM) MODEL 4110 TCPO2/CO2 MONITORING SYSTE | Biochem International, Inc. | 1985-08-21 |
| P810022S010 | TCO2M MODEL 818 MONITOR | Novametrix Medical Systems, Inc. | 1985-07-01 |
| P810022S008 | TCO2M MODEL 818 MONITOR | Novametrix Medical Systems, Inc. | 1985-03-11 |
| P800043S003 | RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO | Radiometer America, Inc. | 1985-02-22 |
| P810037S003 | KONTRON CUTANEOUS PCO2 MONITOR | Kontron Cardiovascular | 1985-01-29 |
| P830008S002 | CUTANIOUS GAS MONITOR | Sensor Medics Corp. | 1985-01-11 |
| P810022S007 | TCO2M MODEL 818 MONITOR | Novametrix Medical Systems, Inc. | 1984-12-04 |
| P830008S001 | CUTANIOUS GAS MONITOR | Sensor Medics Corp. | 1984-10-29 |
| P810022S006 | TCO2M MODEL 818 MONITOR | Novametrix Medical Systems, Inc. | 1984-09-21 |
| P810022S005 | TCO2M MODEL 818 MONITOR | Novametrix Medical Systems, Inc. | 1984-09-13 |
| P810022S004 | TCO2M MODEL 818 MONITOR | Novametrix Medical Systems, Inc. | 1984-06-15 |
| P810022S003 | TCO2M MODEL 818 MONITOR | Novametrix Medical Systems, Inc. | 1984-06-15 |
| P820025S001 | TCPCO2 MONITORING SYSTEM | Narco Scientific | 1984-04-18 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232516 | Sentec Digital Monitoring System (SDMS) tCOM+ | Sentec AG | 2024-05-17 |
| K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet | Sentec AG | 2015-12-17 |
| K131253 | PERIFLUX 6000 | Perimed AB | 2013-10-22 |
| K110474 | PHILIPS INTELLIVUE TCG10 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011-09-30 |
| K101690 | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE | Sentec AG | 2010-12-03 |
| K093154 | TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM | Radiometer Medical Aps | 2010-02-05 |
| K043357 | TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 | Linde Medical Sensors AG | 2005-03-04 |
| K043003 | TCM40 MONITORING SYSTEM | Radiometer Medical Aps | 2005-03-01 |
| K041548 | SENTEC DIGITAL MONITOR MODEL #SDM | Sentec, Inc. | 2004-08-09 |
| K990960 | PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) | Perimed, Inc. | 1999-09-23 |
| K980756 | COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE | Ge Medical Systems Information Technologies | 1998-11-05 |
| K913013 | TCPO2 9260 MODULE - SYSTEM ATHENA | S & W Medico Teknik | 1994-05-03 |
| K905225 | HBO CABLE ASSEMBLY, RADIOMETER TC-02 | Sechrist | 1991-04-10 |
| K900333 | E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT. | Radiometer America, Inc. | 1990-04-16 |
| K891481 | SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE | Siemens Medical Electronics | 1989-09-29 |
| K890517 | TRANSCUTANEOUS O2/CO2 MONITOR | Novametrix Medical Systems, Inc. | 1989-04-14 |
| K883606 | MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS | Hewlett-Packard Co. | 1988-12-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07640121880711 | PSG Cable L | SenTec AG | 2018-11-12 |
| 07640121880704 | PSG Cable K | SenTec AG | 2018-11-12 |
| 07640121880698 | PSG Cable J | SenTec AG | 2018-11-12 |
| 07640121880681 | PSG Cable H | SenTec AG | 2018-11-12 |
| 07640121880674 | PSG Cable G | SenTec AG | 2018-11-12 |
| 07640121880667 | PSG Cable F | SenTec AG | 2018-11-12 |
| 07640121880650 | PSG Cable E | SenTec AG | 2018-11-12 |
| 07640121880643 | PSG Cable D | SenTec AG | 2018-11-12 |
| 07640121880636 | PSG Cable C | SenTec AG | 2018-11-12 |
| 07640121880629 | PSG Cable B | SenTec AG | 2018-11-12 |
| 07640121880612 | PSG Cable A | SenTec AG | 2018-11-12 |
| 07640121880315 | PSG-X | SenTec AG | 2018-11-12 |
| 07640121880490 | Membrane Changer Set | SenTec AG | 2016-08-31 |
| 07640121880568 | Staysite Adhesive | SenTec AG | 2016-08-31 |
| 07640121880513 | V-Sign™ Sensor 2 | SenTec AG | 2016-08-31 |
| 07640121880506 | Membrane Changer Inserts | SenTec AG | 2016-08-31 |
| 07640121880018 | Sentec Digital Monitor | SenTec AG | 2016-08-31 |
| 07640121880445 | Neonatal Starter Set (without Service Gas) | SenTec AG | 2016-08-31 |
| 07640121880438 | Neonatal Starter Set | SenTec AG | 2016-08-31 |
| 07640121880308 | Standard Starter Set (without Service Gas) | SenTec AG | 2016-08-31 |
| 07640121880230 | Multi-Site Attachment Ring for fragile/sensitive skin | SenTec AG | 2016-08-31 |
| 07640121880223 | Multi-Site Attachment Ring for mature/intact skin | SenTec AG | 2016-08-31 |
| 07640121880179 | Digital Sensor Adapter Cable, 750 cm | SenTec AG | 2016-08-31 |
| 07640121880162 | Digital Sensor Adapter Cable, 250 cm | SenTec AG | 2016-08-31 |
| 07640121880094 | Standard Starter Set | SenTec AG | 2016-08-31 |
| 07640121880087 | Membrane Changer (reloadable) / single unit | SenTec AG | 2016-08-31 |
| 07640121880070 | Contact Gel | SenTec AG | 2016-08-31 |
| 07640121880056 | Service gas | SenTec AG | 2016-08-31 |
| 07640121880049 | Ear Clip | SenTec AG | 2016-08-31 |
| 07640121880032 | Digital Sensor Adapter Cable, 150 cm | SenTec AG | 2016-08-31 |