MXT-2 12 Lead Micro-Transmitter

by Medical Electronic Record Exchange

510(k) K933012

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K933012↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK933012	Date14 Mar 1994Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K933012
FDA Product Code: DXH

Device Class: Class II
Regulation: 21 CFR Part 870.2920
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MXT-2 12 Lead Micro-Transmitter is a cardiovascular device that functions as a transmitter and receiver for electrocardiograph telephone systems. It is designed to transmit ECG data through telephone lines for remote monitoring purposes.

This device is supplied by Medical Electronic Record Exchange and has FDA 510K clearance with a K number of K933012. It is a Class II medical device regulated under product code DXH and regulation number 870.2920. The device is intended for cardiovascular applications and is not specified as single-use or reusable in the provided data.