Ultrasound, Sinus
FDA product code LWI · Class II (moderate risk) · 21 CFR 892.1560 · Radiology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960421 | Sinuscan 102/SINUSPRINTLWI · Traditional | Ferguson Medical | 04/16/1997SE |
| K960044 | Ultramax/Model Number A1LWI · Traditional | Entlab OY | 08/02/1996SE |
| K960241 | CPR General Surgery TrayLWI · Traditional | Custom Pack Reliability | 03/22/1996SE |
| K874081 | EnterscanLWI · Traditional | Pie Data Medical BV | 12/31/1987SE |