Edan Instruments, Inc. · Class II · Cleared Jan 25, 2021
| K-number | K202856 |
| Device name | Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28 |
| Applicant | Edan Instruments, Inc. |
| Product code | IYN |
| Device class | Class II |
| Decision date | Jan 25, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 892.1550 |
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