Identifiers
- 510(k) Number
- K854372 FDA 510(k)
- FDA Product Code
- DXJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2450 FDA 510(k)
- Regulation Number
- 870.2450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The VM 781 Slave Scope is a Display, Cathode-Ray Tube, Medical device used for cardiovascular applications. It is a slave scope that provides visual display capabilities in medical settings.
The device is supplied by Nihon Kohden America, Inc. and is classified as Class II with special controls. It received FDA 510(k) clearance on February 28, 1986, with the product code DXJ and regulation number 870.2450.
Frequently asked questions
What is the VM 781 Slave Scope used for?
The VM 781 Slave Scope is a Display, Cathode-Ray Tube, Medical device specifically designed for cardiovascular applications. It provides visual display capabilities in medical settings, allowing clinicians to monitor cardiovascular procedures effectively.
How is the VM 781 Slave Scope supplied?
The VM 781 Slave Scope is supplied by Nihon Kohden America, Inc. It is classified as a Class II medical device with special controls, indicating it requires specific regulatory oversight to ensure safety and effectiveness.
What is the regulatory status of the VM 781 Slave Scope?
The VM 781 Slave Scope received FDA 510(k) clearance on February 28, 1986, with the product code DXJ and regulation number 870.2450. It was determined to be substantially equivalent to other legally marketed devices.
Is the VM 781 Slave Scope reusable or single-use?
The device data does not specify whether the VM 781 Slave Scope is designed for single-use or multiple uses. For information on reprocessing or reuse, users should consult the manufacturer's instructions or contact Nihon Kohden America, Inc. directly.
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: K854372 - VM 781 SLAVE SCOPE | FDA 510 (k), VM 781 SLAVE SCOPE (K854372) — FDA 510 (k) | Innolitics, Vm 781 Slave Scope 510 (k) K854372 - 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 | K854372 | Class II | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden America, Inc.
Sources (1)
- FDA 510(k) K854372 24 fields · synced Sep 22, 2026