The following data is part of a premarket notification filed by Neural Analytics, Inc. with the FDA for Lucid M1 Transcranial Doppler Ultrasound System (lucid M1 System) With 2mhz Transducers.
| Device ID | K160442 |
| 510k Number | K160442 |
| Device Name: | Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) With 2MHz Transducers |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | NEURAL ANALYTICS, INC. 2127 SAWTELLE BLVD Los Angeles, CA 90025 |
| Contact | Jay Yonemoto |
| Correspondent | Javad Seyedzadeh NEURAL ANALYTICS, INC. 2440 South Sepulveda Blvd, Suite 115 Los Angeles, CA 90064 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-17 |
| Decision Date | 2016-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850681007177 | K160442 | 000 |
| 10850681007174 | K160442 | 000 |
| 00850681007009 | K160442 | 000 |
| 00850681007016 | K160442 | 000 |
| 00850681007023 | K160442 | 000 |
| 00850681007030 | K160442 | 000 |
| 00850681007047 | K160442 | 000 |
| 00850681007153 | K160442 | 000 |
| 00850681007160 | K160442 | 000 |
| 00850681007221 | K160442 | 000 |