The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Radiolucent Ecg Electrode Model No: 1680.
| Device ID | K890201 |
| 510k Number | K890201 |
| Device Name: | RADIOLUCENT ECG ELECTRODE MODEL NO: 1680 |
| Classification | Electrode, Electrocardiograph |
| Applicant | MEDTRONIC VASCULAR 60 NEWARK ST. Haverhill, MA 01830 |
| Contact | Edward Shaughnessy |
| Correspondent | Edward Shaughnessy MEDTRONIC VASCULAR 60 NEWARK ST. Haverhill, MA 01830 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-17 |
| Decision Date | 1989-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30653405006224 | K890201 | 000 |
| 20653405004155 | K890201 | 000 |
| 20653405004148 | K890201 | 000 |
| 20653405004131 | K890201 | 000 |
| 20653405004124 | K890201 | 000 |