Multiday, Models 8300 and 8310
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K882888 FDA 510(k)
- FDA Product Code
- GXY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1320 FDA 510(k)
- Regulation Number
- 882.1320 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Multiday, Models 8300 and 8310 is a cutaneous electrode device. It is designed for use in neurology applications.
This device is identified by product code GXY and is classified as a Class II medical device. It received FDA 510(k) clearance on September 30, 1988, under submission number K882888.
Frequently asked questions
What is the primary clinical application for the Multiday 8300 and 8310?
The Multiday models 8300 and 8310 are cutaneous electrode devices specifically designed for use in neurology applications.
What is the regulatory status of the Multiday electrode devices?
These devices are classified as Class II medical devices and received FDA 510(k) clearance on September 30, 1988, under submission number K882888, having been determined to be substantially equivalent to existing devices.
Which product code is associated with these electrodes?
The Multiday models 8300 and 8310 are identified by the product code GXY, which falls under the oversight of the Neurology advisory committee.
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: Multiday, Models 8300 and 8310 - Beudamed, K882888 FDA 510 (k) - MULTIDAY | Medical Devices, Inc., PDF K882888 - Multiday, Models 8300 and 8310, 510 (k) Premarket Notification
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K882888 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medical Devices Inc.
- FDA Applicant
- Medical Devices, Inc.
Sources (1)
- FDA 510(k) K882888 24 fields · synced Sep 21, 2026