The following data is part of a premarket notification filed by Syntermed with the FDA for Neuroq 3.8.
| Device ID | K180077 |
| 510k Number | K180077 |
| Device Name: | NeuroQ 3.8 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Syntermed 245 South Owens Drive Anaheim, CA 92808 |
| Contact | Kenneth Van Train |
| Correspondent | Kenneth Van Train Syntermed 245 South Owens Drive Anaheim, CA 92808 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-10 |
| Decision Date | 2018-08-16 |
| Summary: | summary |