The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Tcm40 Monitoring System.
| Device ID | K043003 |
| 510k Number | K043003 |
| Device Name: | TCM40 MONITORING SYSTEM |
| Classification | Monitor, Carbon-dioxide, Cutaneous |
| Applicant | RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Contact | Pierre Pelletier |
| Correspondent | Pierre Pelletier RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Product Code | LKD |
| Subsequent Product Code | DQA |
| Subsequent Product Code | KLK |
| Subsequent Product Code | LPP |
| CFR Regulation Number | 868.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-01 |
| Decision Date | 2005-03-01 |
| Summary: | summary |