The following data is part of a premarket notification filed by Neuroscan with the FDA for Nuamps.
Device ID | K023536 |
510k Number | K023536 |
Device Name: | NUAMPS |
Classification | Non-normalizing Quantitative Electroencephalograph Software |
Applicant | NEUROSCAN 7850 PASEO DEL NORTE SUITE 101 El Paso, TX 79912 |
Contact | Elvira Garcia |
Correspondent | Elvira Garcia NEUROSCAN 7850 PASEO DEL NORTE SUITE 101 El Paso, TX 79912 |
Product Code | OLT |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-21 |
Decision Date | 2003-01-15 |
Summary: | summary |