Company ยท US
Nicolet Instrument Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1993. 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 |
|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | 2 |
| GWQ | Full-Montage Standard Electroencephalograph | 2 |
| IKN | Electromyograph, Diagnostic | 2 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 1 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 1 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 |
| GWK | Conditioner, Signal, Physiological | 1 |
| GWN | Nystagmograph | 1 |
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | 1 |
| GYC | Electrode, Cortical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 14, 1993 | K921138 | NICOLET ULTRASOM ACQUISITION STATION Nicolet Instrument Corp. | GWQ |
| Nov 23, 1992 | K923315 | NICOLET ARK SYSTEM Nicolet Instrument Corp. | GWF |
| Nov 5, 1992 | K921927 | NICOLET VOYAGEUR Nicolet Instrument Corp. | GWQ |
| Feb 7, 1992 | K915652 | NICOLET PORATBLE SPIRIT SYSTEM Nicolet Instrument Corp. | GWF |
| Jun 7, 1991 | K905632 | NICOLET MAPLELEAF SYSTEM Nicolet Instrument Corp. | GWJ |
| Apr 30, 1990 | K897154 | NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE Nicolet Instrument Corp. | ESD |
| Mar 9, 1990 | K894629 | NICOLET BEAM II SYSTEM Nicolet Instrument Corp. | GWS |
| Feb 8, 1990 | K896477 | NICOLET REAL EAR ANALYZER Nicolet Instrument Corp. | ETW |
| Jun 5, 1989 | K883781 | NICOLET NEUROPORT/ACE SYSTEM Nicolet Instrument Corp. | IKN |
| Mar 16, 1989 | K890495 | NICOLET VIKING II SYSTEM Nicolet Instrument Corp. | IKN |
| Nov 23, 1988 | K884294 | NICOLET NYSTAR PLUS SYSTEM Nicolet Instrument Corp. | GWN |
| Oct 19, 1988 | K882599 | NICOLET BRAINLAB SYSTEM Nicolet Instrument Corp. | GWK |
| Oct 18, 1988 | K882053 | NICOLET EPIDURAL SPINAL ELECTRODE Nicolet Instrument Corp. | GYC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||