Neurosearch-24 or Nrs-24
by Lexicor Medical Technology, Inc. 2 variants
510(k) K915820
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK915820 | Date8 Feb 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OLT
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The NEUROSEARCH-24 OR NRS-24 is a Non-Normalizing Quantitative Electroencephalograph Software device designed for the precise, objective, and consistent characterization of brain mapping. It is classified as a Class II medical device under the FDA's 510(k) clearance program, with a decision of Substantially Equivalent. The device is intended for use in neurology and is associated with the NE (Neurology) advisory committee.
The device is supplied as software and is intended for single-use applications. It does not specify storage conditions or MRI safety. The manufacturer, Lexicor Medical Technology, Inc., is located in Boulder, Colorado, and the device is regulated under the FDA's 510(k) program with the K915820 clearance number.