The following data is part of a premarket notification filed by Natus Manufacturing Limited with the FDA for Myoject Luer Lock Needle Electrode.
| Device ID | K161430 |
| 510k Number | K161430 |
| Device Name: | Myoject Luer Lock Needle Electrode |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | Natus Manufacturing Limited IDA Business Park Gort, IE |
| Contact | Michael Galvin |
| Correspondent | Michael Galvin Natus Manufacturing Limited IDA Business Park Gort, IE |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-23 |
| Decision Date | 2017-03-02 |
| Summary: | summary |