The following data is part of a premarket notification filed by Radiometer Medical A/s with the FDA for Tcm400.
| Device ID | K001866 |
| 510k Number | K001866 |
| Device Name: | TCM400 |
| Classification | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia |
| Applicant | RADIOMETER MEDICAL A/S AKANDEVEJ 21 Dk-2700 Bronshoj, DK Dk-2700 |
| Contact | Kristen Rono |
| Correspondent | Kristen Rono RADIOMETER MEDICAL A/S AKANDEVEJ 21 Dk-2700 Bronshoj, DK Dk-2700 |
| Product Code | LPP |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-20 |
| Decision Date | 2000-12-07 |