Skip to content

Servomed Arrhycomp Central Monitor Sys

by Litton Medical Electronics

510(k) K840899

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 NumberK840899 Date20 Nov 1984ClearedStatusActive

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  • Withdrawn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
DSI
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 detector and alarm for arrhythmia, classified as a cardiovascular medical device under FDA regulation number 870.1025. It is designed to monitor and detect arrhythmias, providing alarms based on cardiac rhythm analysis.

It was cleared through the FDA 510(k) process under K840899 with a traditional clearance pathway and is substantially equivalent to a predicate device. The device is manufactured by Litton Medical Electronics and is intended for use in cardiovascular monitoring settings.

Other devices from Litton Medical Electronics

See all devices from Litton Medical Electronics →