The following data is part of a premarket notification filed by Spectrum Dynamics Medical Ltd. with the FDA for Veriton Nm.
| Device ID | K180514 |
| 510k Number | K180514 |
| Device Name: | VERITON NM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Spectrum Dynamics Medical Ltd. 22 Bareket St. North Industrial Park, IL 3088900 |
| Contact | Igor Naroditsky |
| Correspondent | Igor Naroditsky Spectrum Dynamics Medical Ltd. 22 Bareket St. North Industrial Park, IL 3088900 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-27 |
| Decision Date | 2018-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290108670103 | K180514 | 000 |