MEC-I-Tron Mini, Model M-2
by Meyer Equipment Company, Inc.
510(k) K895289
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895289 | Date19 Jan 1990 | 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- Withdrawn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
- GZJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The MEC-I-Tron Mini, Model M-2 is a neurological monitoring device designed for electrophysiological studies. Classified under product code GZJ, it is intended for recording and analyzing electrical activity in the nervous system, supporting diagnostic and research applications in neurology. Its compact form factor distinguishes it from larger systems while maintaining core functionality for signal acquisition and processing.
This device is supplied as a reusable medical instrument, intended for use in clinical or research settings where neurological assessments are conducted. It requires proper maintenance and calibration to ensure accurate signal integrity. The MEC-I-Tron Mini, Model M-2 holds FDA 510(k) clearance (K895289) under the Traditional pathway, with a decision date of January 19, 1990, and is regulated as a Class II device under the advisory jurisdiction of the Neurology Committee (NE). No specific sterility or MRI safety information is provided in the available data.
Other devices from Meyer Equipment Company, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the MEC-I-Tron Mini, Model M-2 used for?
The MEC-I-Tron Mini, Model M-2 is designed for electrophysiological studies, specifically to record and analyze electrical activity in the nervous system. This supports diagnostic and research applications in neurology by providing accurate signal acquisition and processing in a compact form factor.
Is the MEC-I-Tron Mini, Model M-2 reusable or single-use?
The MEC-I-Tron Mini, Model M-2 is supplied as a reusable medical instrument. It is intended for repeated use in clinical or research settings, provided it undergoes proper maintenance and calibration to ensure reliable signal integrity and safety.
Does the MEC-I-Tron Mini, Model M-2 require sterilization?
The available data does not specify any sterility requirements for the MEC-I-Tron Mini, Model M-2. As a reusable device, it should be cleaned and maintained according to manufacturer guidelines to prevent contamination and ensure accurate performance.
What regulatory pathway does the MEC-I-Tron Mini, Model M-2 follow?
The MEC-I-Tron Mini, Model M-2 holds FDA 510(k) clearance (K895289) under the Traditional pathway, with a decision date of January 19, 1990. It is classified as a Class II device under the advisory jurisdiction of the Neurology Committee (NE).
How does the compact form factor of the MEC-I-Tron Mini, Model M-2 benefit users?
The compact design of the MEC-I-Tron Mini, Model M-2 allows for easier integration into various clinical or research environments without sacrificing core functionality. This makes it suitable for settings where space is limited, while still providing reliable electrophysiological monitoring capabilities.