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 |