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 |