The following data is part of a premarket notification filed by Neural Analytics, Inc. with the FDA for Neuralbot.
| Device ID | K180455 |
| 510k Number | K180455 |
| Device Name: | NeuralBot |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Neural Analytics, Inc. 2440 S Sepulveda Blvd. Suite 115 Los Angeles, CA 90064 |
| Contact | Javad Seyedzadeh |
| Correspondent | Javad Seyedzadeh Neural Analytics, Inc. 2440 S Sepulveda Blvd. Suite 115 Los Angeles, CA 90064 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | OQQ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-20 |
| Decision Date | 2018-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850681007122 | K180455 | 000 |
| 00850681007115 | K180455 | 000 |
| 10850681007198 | K180455 | 000 |
| 00850681007184 | K180455 | 000 |
| 00850681007443 | K180455 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NEURALBOT 87761310 not registered Live/Pending |
Neural Analytics, Inc. 2018-01-18 |