The following data is part of a premarket notification filed by Neurochaos Solutions, Inc. with the FDA for Varia-nci.
| Device ID | K141462 |
| 510k Number | K141462 |
| Device Name: | VARIA-NCI |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | NEUROCHAOS SOLUTIONS, INC. 12416 FAIRFAX RIDGE PLACE Austin, TX 78738 |
| Contact | Elisa Maldonado-holmertz |
| Correspondent | Elisa Maldonado-holmertz NEUROCHAOS SOLUTIONS, INC. 12416 FAIRFAX RIDGE PLACE Austin, TX 78738 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-03 |
| Decision Date | 2014-11-19 |
| Summary: | summary |