The following data is part of a premarket notification filed by Contour Electrodes, Inc. with the FDA for Phantom Radiotranslucent Ecg Monitoring Electrode.
| Device ID | K900682 |
| 510k Number | K900682 |
| Device Name: | PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | CONTOUR ELECTRODES, INC. 100 S. 13TH ST. Herrin, IL 62948 |
| Contact | Paris Walker |
| Correspondent | Paris Walker CONTOUR ELECTRODES, INC. 100 S. 13TH ST. Herrin, IL 62948 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-13 |
| Decision Date | 1990-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838006793 | K900682 | 000 |
| 20884838006762 | K900682 | 000 |