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Servomed Standard SMS 104

by Litton Medical Electronics

510(k) K832041

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 NumberK832041 Date26 Oct 1983ClearedStatusActive

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  • Withdrawn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
DRT
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Servomed Standard SMS 104 is a cardiac monitor that includes a cardiotachometer and rate alarm, classified as a Class 2 cardiovascular device. It is intended for monitoring cardiac activity and providing rate alarms, as indicated by its regulatory classification and device name.

The device is supplied as a single-use monitor and is not reusable. It is not specified as sterile, and no storage conditions are provided. The device has received FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent (SESE) issued on October 26, 1983.

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