The following data is part of a premarket notification filed by Medicotest A/s with the FDA for Blue Sensor, Disposable Ecg Electrodes For Anaesthesia.
| Device ID | K020382 |
| 510k Number | K020382 |
| Device Name: | BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA |
| Classification | Electrode, Electrocardiograph |
| Applicant | MEDICOTEST A/S 1800 MASSCHUSETTS AVE., N.W. SUITE 200 Washington, DC 20036 -1221 |
| Contact | Emalee G Murphy |
| Correspondent | Emalee G Murphy MEDICOTEST A/S 1800 MASSCHUSETTS AVE., N.W. SUITE 200 Washington, DC 20036 -1221 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-05 |
| Decision Date | 2002-06-28 |