Philips Intellivue TCG10
FDA 510(k) K110474 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
510(k) numberK110474
Submission
- Device name
- Philips Intellivue TCG10
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Boeblingen, Baden-Wuerttemberg, DE - Received
- February 18, 2011
- Decision date
- September 30, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKD – Monitor, Carbon-Dioxide, Cutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2480
- Specialty
- Anesthesiology
Other 510(k)s with product code LKD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232516 | Sentec Digital Monitoring System (SDMS) tCOM+LKD · Traditional | Sentec AG | 05/17/2024SE |
| K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…LKD · Traditional | Sentec AG | 12/17/2015SE |
| K131253 | Periflux 6000LKD · Abbreviated | Perimed AB | 10/22/2013SE |
| K101690 | Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableLKD · Traditional | Sentec AG | 12/03/2010SE |
| K093154 | TCM Tosca Monitoring System, TCM Combim Monitoring SystemLKD · Traditional | Radiometer Medical Aps | 02/05/2010SE |
| K043357 | Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009LKD · Traditional | Linde Medical Sensors AG | 03/04/2005SE |
| K043003 | TCM40 Monitoring SystemLKD · Abbreviated | Radiometer Medical Aps | 03/01/2005SE |
| K041548 | Sentec Digital Monitor Model #SdmLKD · Traditional | Sentec, Inc. | 08/09/2004SE |
| K990960 | Perimed Transcutaneous PO2 and PCO2 Monitor (PF5040)LKD · Traditional | Perimed, Inc. | 09/23/1999SE |
| K980756 | Corometrics Transcutaneous TCPO2/CO2 ModuleLKD · Traditional | Ge Medical Systems Information Technologies | 11/05/1998SE |
More from Ge Medical Systems Information Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K141015 | Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…MHX · Special | 05/19/2014SE |
| K132320 | Intellivue CL Respiration PodBZQ · Traditional | 03/26/2014SE |
| K131872 | Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550MHX · Special | 10/17/2013SE |
| K131829 | Intellivue Patient MonitorMHX · Special | 08/16/2013SE |
| K130849 | Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450MHX · Special | 06/14/2013SE |
| K120366 | Intellivue Patient MonitorMHX · Abbreviated | 07/18/2012SE |
| K113441 | Physiological Monitor, Patient MonitorMHX · Traditional | 03/22/2012SE |
| K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…DXJ · Abbreviated | 10/04/2011SE |
| K111083 | Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50HGM · Abbreviated | 08/17/2011SE |
| K110622 | Intellivue Patient MonitorMHX · Special | 03/31/2011SE |
Questions and answers
When was Philips Intellivue TCG10 cleared by the FDA?
Philips Intellivue TCG10 (K110474) received a 510(k) decision of Substantially Equivalent on September 30, 2011, 224 days after the submission was received.
What is the product code of K110474?
The FDA product code is LKD – Monitor, Carbon-Dioxide, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 868.2480.