Company ยท US
Nicolet Biomedical Instruments
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1988. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IKN | Electromyograph, Diagnostic | 6 |
| GWK | Conditioner, Signal, Physiological | 2 |
| GWQ | Full-Montage Standard Electroencephalograph | 2 |
| DQC | Phonocardiograph | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 1 |
| ETN | Stimulator, Nerve | 1 |
| EWO | Audiometer | 1 |
| GWE | Stimulator, Photic, Evoked Response | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 |
| GWL | Amplifier, Physiological Signal | 1 |
| GWM | Device, Monitoring, Intracranial Pressure | 1 |
| GWN | Nystagmograph | 1 |
| GXY | Electrode, Cutaneous | 1 |
| GXZ | Electrode, Needle | 1 |
| HLX | Photostimulator, Ac-Powered | 1 |
| HLZ | Electrode, Corneal | 1 |
| HOX | Chart, Visual Acuity | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 22, 1988 | K880573 | MODIFIED NICOLET VIKING SYSTEM Nicolet Biomedical Instruments | IKN |
| Dec 8, 1987 | K873736 | NICOLET DIGITAL TWO PIECE HEARING AID Nicolet Biomedical Instruments | ESD |
| Nov 20, 1987 | K873964 | NICOLET DISPOSABLE PRASS PROBE Nicolet Biomedical Instruments | ETN |
| Oct 26, 1987 | K873535 | NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM Nicolet Biomedical Instruments | GWQ |
| Jul 16, 1987 | K871678 | NICOLET AMP 6R11 SYSTEM Nicolet Biomedical Instruments | GWL |
| Sep 16, 1986 | K862592 | PHOENIX SYSTEM SEVEN. Nicolet Biomedical Instruments | EWO |
| Nov 27, 1985 | K851190 | NYSTAGMOGRAPH EOG/ENG ANALYSES Nicolet Biomedical Instruments | GWN |
| Apr 11, 1985 | K850259 | ELECTROENCEPHALOGRAPH EEG Nicolet Biomedical Instruments | GWQ |
| Apr 11, 1985 | K850108 | EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG Nicolet Biomedical Instruments | GXY |
| Apr 11, 1985 | K850107 | CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE Nicolet Biomedical Instruments | GXZ |
| Apr 11, 1985 | K843598 | BRAIN FUNCTION MAPPING OPTION FOR PATHF Nicolet Biomedical Instruments | GWK |
| Aug 3, 1984 | K842956 | NICOLET VIKING Nicolet Biomedical Instruments | IKN |
| Jul 20, 1984 | K842613 | COMPACT VISUAL Nicolet Biomedical Instruments | IKN |
| Jul 20, 1984 | K842612 | COMPACT AUDITORY Nicolet Biomedical Instruments | IKN |
| Jul 20, 1984 | K842611 | CA2000 Nicolet Biomedical Instruments | IKN |
| Jul 28, 1983 | K831896 | COMPACT FOUR Nicolet Biomedical Instruments | GWF |
| Jul 12, 1983 | K830702 | NICOLET EMG SATELLITE Nicolet Biomedical Instruments | IKN |
| Mar 8, 1983 | K830579 | MULTI-SIGNAL AUDITORY STIMULATOR SM700 Nicolet Biomedical Instruments | GWJ |
| Aug 31, 1982 | K822215 | NIC OPTRONICS CS-2000 Nicolet Biomedical Instruments | HOX |
| Jan 22, 1982 | K813399 | ERG-JET ELECTRODE Nicolet Biomedical Instruments | HLZ |
| Nov 16, 1981 | K812331 | VTS-1000 VISUAL TESTING SYSTEM Nicolet Biomedical Instruments | HLX |
| Nov 12, 1980 | K802149 | TM-5 INTRACRANIAL PRESSURE MONITOR Nicolet Biomedical Instruments | GWM |
| Aug 4, 1980 | K801604 | PATHFINDER ELECTRODIAGNOSTIC SYSTEM Nicolet Biomedical Instruments | GWK |
| Jan 24, 1980 | K792466 | NIC-200 VENTRICULAR FUNCTION ANALYZER Nicolet Biomedical Instruments | DQC |
| May 23, 1979 | K790570 | STIMULATOR, NIC-106 VISUAL Nicolet Biomedical Instruments | GWE |
| Sep 6, 1977 | K771449 | ARTEOIAL TONOMETER ML-105 Nicolet Biomedical Instruments | DXN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||