Company ยท US
Nicolet Biomedical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2003. Name variants (Inc, Corp, punctuation) are merged.
18510(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 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 |
| JAF | Monitor, Ultrasonic, Nonfetal | 2 |
| ETN | Stimulator, Nerve | 1 |
| EWO | Audiometer | 1 |
| GXY | Electrode, Cutaneous | 1 |
| GXZ | Electrode, Needle | 1 |
| GYC | Electrode, Cortical | 1 |
| HCC | Device, Biofeedback | 1 |
| HGM | System, Monitoring, Perinatal | 1 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 1 |
| JOP | Transducer, Ultrasonic | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
| OLW | Index-Generating Electroencephalograph Software | 1 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 21, 2003 | K020754 | NICOLET PIONEER TC8080 Nicolet Biomedical | IYN |
| Aug 23, 2002 | K021986 | BRAINET Nicolet Biomedical, Inc. | GXY |
| Jun 24, 2002 | K021144 | SUBDURAL STRIP ELECTRODE Nicolet Biomedical, Inc. | GYC |
| Apr 22, 2002 | K020218 | SNAP EEG MONITOR Nicolet Biomedical, Inc. | OLW |
| Apr 18, 2002 | K013281 | VERSALAB APM Nicolet Biomedical | HGM |
| Apr 17, 2002 | K020955 | NICOLET ELECTROCAUTERY DETECTOR Nicolet Biomedical, Inc. | ETN |
| Dec 20, 2001 | K013419 | NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM Nicolet Biomedical | LLZ |
| Sep 6, 2001 | K011823 | BIOREHAB SYSTEM Nicolet Biomedical, Inc. | HCC |
| Sep 6, 2001 | K011818 | STERILE EMG ELECTRODES Nicolet Biomedical, Inc. | IKT |
| Jul 26, 2001 | K011135 | GSI AUDERA Nicolet Biomedical | EWO |
| Mar 19, 2001 | K010019 | STERILE SUBDERMAL NEEDLE ELECTRODES Nicolet Biomedical, Inc. | GXZ |
| Mar 9, 2001 | K010521 | NICOLET VERSALAB Nicolet Biomedical | JAF |
| Nov 30, 2000 | K002766 | NICOLET VASOGUARD Nicolet Biomedical | JOP |
| Jun 29, 2000 | K993939 | NICOLET EME LEGEND TC22 Nicolet Biomedical | IYN |
| Nov 3, 1999 | K991054 | BRAVO MULTI-MODALITY SYSTEM Nicolet Biomedical, Inc. | GWQ |
| Aug 7, 1998 | K982635 | CAREDOP II Nicolet Biomedical | JAF |
| Jun 25, 1997 | K971331 | SATELLITE Nicolet Biomedical, Inc. | GWQ |
| May 15, 1995 | K950270 | NMI SOFTWARE Nicolet Biomedical, Inc. | OMB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||