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PER, Model Memo

by Medical Monitors Pty., Ltd.

510(k) K030218

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030218 Date23 Jun 2003ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
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, 22 Sep 2026

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

The device is a transmitter and receiver, electrocardiograph, telephone, as defined in the FDA 510(k) submission. It is classified as a Class II medical device under regulation number 870.2920.

It was cleared via the traditional 510(k) pathway under K030218, with a decision date of June 23, 2003, and is substantially equivalent to a predicate device. The device is manufactured by Medical Monitors Pty., Ltd. and is intended for use in cardiovascular applications as indicated by the advisory committee classification.

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