Company ยท CA
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2024. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | 4 |
| OLV | Standard Polysomnograph With Electroencephalograph | 2 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 2 |
| GWE | Stimulator, Photic, Evoked Response | 1 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 |
| OMA | Amplitude-Integrated Electroencephalograph | 1 |
| OMC | Reduced- Montage Standard Electroencephalograph | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 19, 2024 | K242930 | Natus BrainWatch System Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | OMC |
| Mar 8, 2024 | K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | GWJ |
| Apr 13, 2021 | K203500 | RetCam Envision Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | HKI |
| May 18, 2020 | K200878 | Natus NeuroWorks Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | OMB |
| Jun 15, 2018 | K173936 | Natus Photic Stimulator Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | GWE |
| Jun 14, 2018 | K180290 | Natus Brain Monitor Amplifier Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | GWQ |
| Mar 14, 2018 | K180421 | Natus NeuroWorks Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | OMB |
| Mar 9, 2018 | K173690 | Grass TWin Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | OLV |
| Feb 22, 2018 | K180181 | Natus Quantum Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek), CA | GWQ |
| Nov 3, 2017 | K172711 | Comet-PLUS Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | OLV |
| Dec 14, 2016 | K163163 | XLTEK EMU40EX EEG Headbox Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | GWQ |
| Nov 4, 2016 | K162595 | Trex_HD Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | GWQ |
| Jun 3, 2016 | K152301 | Background Pattern Classification [BPc(TM)] Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | OMA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||