Sentec Digital Monitor Model #Sdm
FDA 510(k) K041548 · Sentec, Inc.
510(k) numberK041548
Submission
- Device name
- Sentec Digital Monitor Model #Sdm
- Applicant
- Sentec, Inc.
Egale, WI, US - Received
- June 9, 2004
- Decision date
- August 9, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K110474 | Philips Intellivue TCG10LKD · Abbreviated | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 09/30/2011SE |
| 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 |
| 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 |
|---|---|---|
| K243765 | LuMon(TM) SystemQEB · Traditional | 08/07/2025SE |
| K232516 | Sentec Digital Monitoring System (SDMS) tCOM+LKD · Traditional | 05/17/2024SE |
| K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…LKD · Traditional | 12/17/2015SE |
| K101690 | Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableLKD · Traditional | 12/03/2010SE |
| K071672 | Sentec Digital Monitoring SystemDQA · Traditional | 09/12/2007SE |
| K862340 | Sentec Laser Guide Line, Model SGL-05IZW · Traditional | 07/11/1986SE |
Questions and answers
When was Sentec Digital Monitor Model #Sdm cleared by the FDA?
Sentec Digital Monitor Model #Sdm (K041548) received a 510(k) decision of Substantially Equivalent on August 9, 2004, 61 days after the submission was received.
What is the product code of K041548?
The FDA product code is LKD – Monitor, Carbon-Dioxide, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 868.2480.