Neuromed Octrode Model MNT-98 Neurostimulator Tran
by Neuromed, Inc. 510(k)
Active
510(k) K930498
Overview
This is an implanted spinal cord stimulator for pain relief, classified as a Class II device under FDA regulation 882.5880 with product code GZB. It is a neurostimulator device designed for neurological applications.
The device received FDA 510(k) clearance (K930498) on December 12, 1994, following a traditional review process. It is manufactured by Neuromed, Inc. at 5000-A Oakes Rd., Suite A, Ft. Lauderdale, FL 33314.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930498 | Date12 Dec 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GZB
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5880
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Neuromed, Inc.
Questions
What is the Neuromed Octrode Model MNT-98 Neurostimulator Trans used for?
This device is an implanted spinal cord stimulator designed to provide pain relief through neurological stimulation, specifically indicated for managing chronic pain via spinal cord stimulation as an implanted neurostimulator.
How was the Neuromed Octrode Model MNT-98 Neurostimulator Trans approved for market?
It received FDA 510(k) clearance through a traditional review process on December 12, 1994, under submission K930498, demonstrating substantial equivalence to a legally marketed predicate device.
What regulatory classification and product code apply to the Neuromed Octrode Model MNT-98 Neurostimulator Trans?
The device is classified as a Class II medical device under FDA regulation 882.5880 and is assigned product code GZB, which corresponds to implanted spinal cord stimulators for pain relief.