The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Model 1730 Neotrode With Attached Leadwire.
| Device ID | K901555 |
| 510k Number | K901555 |
| Device Name: | MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE |
| Classification | Electrode, Electrocardiograph |
| Applicant | MEDTRONIC VASCULAR 60 NEWARK ST. Haverhill, MA 01830 |
| Contact | Janice M Pevide |
| Correspondent | Janice M Pevide 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 | 1990-04-03 |
| Decision Date | 1990-07-18 |