Identifiers
- 510(k) Number
- K972244 FDA 510(k)
- FDA Product Code
- GZJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The NT2000 is a neurodiagnostic device classified under FDA Product Code GZJ, designed for neurological applications. It functions as a nerve conduction testing instrument, enabling the assessment of nerve and muscle function by measuring electrical activity in response to stimuli.
The NT2000 is supplied by Bio-Medical Research, Ltd. and is intended for use in clinical settings, adhering to electrical safety standards per IEC 601-1 and electromagnetic compatibility requirements per IEC 601-1-2. It is a reusable device, subject to final performance testing to minimize electrical and mechanical hazards. Authorized under FDA 510(k) clearance (K972244), it falls under Class II regulatory classification.
Frequently asked questions
What clinical applications is the NT2000 primarily used for in a hospital setting?
The NT2000 is designed for nerve conduction testing, which helps clinicians assess nerve and muscle function by measuring electrical responses to stimuli. This is particularly useful in diagnosing conditions like peripheral neuropathy, carpal tunnel syndrome, or other neurological disorders affecting nerve pathways.
Is the NT2000 a single-use or reusable device, and what maintenance is required?
The NT2000 is a reusable device, meaning it is intended for repeated use in clinical settings. To ensure safety and performance, it must undergo final performance testing after each use to minimize electrical and mechanical hazards, as outlined in its design specifications.
What safety and compatibility standards does the NT2000 meet?
The NT2000 adheres to electrical safety standards defined by IEC 601-1 and electromagnetic compatibility requirements per IEC 601-1-2. These standards ensure the device operates safely in clinical environments without interfering with other medical equipment.
How is the NT2000 regulated, and what does its FDA clearance mean for buyers?
The NT2000 holds FDA 510(k) clearance under the classification code K972244, determined to be substantially equivalent to a legally marketed device in the U.S. This means it meets regulatory requirements for safety and effectiveness as evaluated by the FDA, allowing it to be legally marketed and used in clinical settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NT2000 (K972244) — FDA 510(k) | Innolitics, Nt2000 510 (k) FDA Premarket Notification K972244 BIO-MEDICAL RESEARCH ..., Nt2000 - Beudamed, Bio-Medical-Research-L-T-D FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972244 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Medical Research, Ltd.
Sources (1)
- FDA 510(k) K972244 24 fields · synced Sep 19, 2026