The following data is part of a premarket notification filed by Natus Manufacturing Limited with the FDA for Dantec Dcn Disposable Concentric Needle Electrodes-25mm, Dantec Dcn Disposable Concentric Needle Electrodes-37mm, Dantec Dcn Disposable Concentric Needle Electrodes-50mm, Dantec Dcn Disposable Concentric Needle Electrodes-75mm.
| Device ID | K143433 |
| 510k Number | K143433 |
| Device Name: | Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm |
| 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 | 2014-12-01 |
| Decision Date | 2015-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830062619 | K143433 | 000 |
| 00382830062602 | K143433 | 000 |
| 00382830062596 | K143433 | 000 |
| 00382830062589 | K143433 | 000 |
| 00382830062572 | K143433 | 000 |
| 00382830050654 | K143433 | 000 |