The following data is part of a premarket notification filed by Neuro Scan Labs with the FDA for Scan Lt40 (40 Channels).
Device ID | K001564 |
510k Number | K001564 |
Device Name: | SCAN LT40 (40 CHANNELS) |
Classification | Non-normalizing Quantitative Electroencephalograph Software |
Applicant | NEURO SCAN LABS 5700 CROMO DR., SUITE 100 El Paso, TX 79912 -5538 |
Contact | David B Jones |
Correspondent | David B Jones NEURO SCAN LABS 5700 CROMO DR., SUITE 100 El Paso, TX 79912 -5538 |
Product Code | OLT |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-19 |
Decision Date | 2000-11-24 |