The following data is part of a premarket notification filed by Medtronic Functional Diagnostics A/s with the FDA for Disposable Monopolar Needle Electrode, Dmf 25; Dmn 25; Dmf 37; Dmn 37; Dmn 50; Dmn 75.
| Device ID | K990375 |
| 510k Number | K990375 |
| Device Name: | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S TONSBAKKEN 16-18 SKOVLUNDE Copenhagen, DK Dk-2740 |
| Contact | Ann-christine Jonsson |
| Correspondent | Ann-christine Jonsson MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S TONSBAKKEN 16-18 SKOVLUNDE Copenhagen, DK Dk-2740 |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-08 |
| Decision Date | 1999-03-09 |
| Summary: | summary |