MX1002 Cable-Cal
FDA 510(k)Class II (US FDA 510(k))
by Medex, Inc.
Identifiers
- 510(k) Number
- K880696 FDA 510(k)
- FDA Product Code
- DXG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1435 FDA 510(k)
- Regulation Number
- 870.1435 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MX1002 Cable-Cal is a Computer, Diagnostic, Pre-Programmed, Single-Function device designed for calibrating and testing electrical cables, particularly in cardiovascular diagnostic applications. It provides automated measurements to ensure accuracy and reliability of cable performance in medical instrumentation.
This device is supplied as a reusable, non-sterile instrument intended for use in clinical or laboratory settings. It operates under FDA 510(k) clearance (K880696) under the Cardiovascular advisory committee, adhering to regulation 870.1435. No MRI safety or single-use specifications are indicated in the regulatory data.
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: MX1002 CABLE-CAL TM (K880696) — FDA 510 (k) | Innolitics, Mx1002 Cable-cal Tm - Beudamed, PDF K880696 MX1002 CABLE-CAL TM - 510kdatabase.net, Mx1002 Cable-cal Tm 510 (k) FDA Premarket Notification K880696 MEDEX, INC., 510 (k) K880696 — MX1002 CABLE-CAL TM — RegDataLab
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K880696 | Class II | Active |
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Manufacturer
- Manufacturer
- Medex, Inc.
Sources (1)
- FDA 510(k) K880696 24 fields · synced Sep 19, 2026