510(k) K093154
- Device
- TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
- Applicant
- RADIOMETER MEDICAL APS
- 510(k) number
- K093154
- Product code
- LKD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-02-05
- Date received
- 2009-10-06
- Regulation
- 868.2480
- Classification name
- Monitor, Carbon-dioxide, Cutaneous
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANA HELLMAN
- Address
- Akandevej 21 Dk-2700 Bronshoj DK
FDA Registration Numbers#
- 2020676
- 3012409105
- 3012866928
- 8030885
- 3012528160
- 3002807968
- 3007490412
- 3013596024
- 3013500228
- 3000126629
- 3004149774
- 3003263092
- 3016701404
- 9610816
- 3013513377
- 9614470
- 3009077524
- 3016618143
Source Documents#
Other 510(k) Records For Product Code LKD #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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