Panels › Ear, Nose, Throat › Product code EQL · Class 1
Laryngostroboscope
Regulation 874.4750
0510(k)s in 12 months (8 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in EQL
| Company | 510(k)s | Recalls |
|---|---|---|
| Kay Elemetrics Corp. | 2 | 0 |
| Bruel & Kjaer Industri A/S | 1 | 0 |
| Jedmed Instrument Co. | 1 | 0 |
| Kelleher Corp. | 1 | 0 |
| Parke-Davis Co. | 1 | 0 |
| Pentax Medical Company | 0 | 1 |
| Pentax of America Inc | 0 | 1 |
| Pentax Precision Instrument Corp. | 1 | 0 |
| Richard Wolf Medical Instruments Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2016 | Pentax of America Inc Rigid Laryngostroboscopes
The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally Terminated |
EQL | None listed |
| Jun 28, 2016 | Pentax Medical Company Laryngo Stroboscope
Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, ti Terminated |
EQL | None listed |
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