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 |