The following data is part of a premarket notification filed by Neurosoft, Inc. with the FDA for Curry Multimodal Neuroimaging Software.
Device ID | K001781 |
510k Number | K001781 |
Device Name: | CURRY MULTIMODAL NEUROIMAGING SOFTWARE |
Classification | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
Applicant | NEUROSOFT, INC. 5700 CROMO DR. SUITE 100 El Paso, TX 79912 |
Contact | David B Jones |
Correspondent | David B Jones NEUROSOFT, INC. 5700 CROMO DR. SUITE 100 El Paso, TX 79912 |
Product Code | OLX |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-13 |
Decision Date | 2001-02-05 |