The following data is part of a premarket notification filed by Lexicor Medical Technology, Inc. with the FDA for Neurosearch-24 Or Nrs-24.
Device ID | K904269 |
510k Number | K904269 |
Device Name: | NEUROSEARCH-24 OR NRS-24 |
Classification | Full-montage Standard Electroencephalograph |
Applicant | LEXICOR MEDICAL TECHNOLOGY, INC. 2585 CENTRAL AVE. Boulder, CO 80301 |
Contact | Michael Hickey |
Correspondent | Michael Hickey LEXICOR MEDICAL TECHNOLOGY, INC. 2585 CENTRAL AVE. Boulder, CO 80301 |
Product Code | GWQ |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-18 |
Decision Date | 1991-06-04 |