Cleared Traditional

K840523 - SERVOMED PULSE AMPLIFIER MODULE-206-

K840523 is an FDA 510(k) clearance for SERVOMED PULSE AMPLIFIER MODULE-206-, manufactured by Litton Medical Electronics. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K840523 · Litton Medical Electronics · Cardiovascular device
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Oct 1984
Decision
265d
Days
Class 2
Risk

K840523 is an FDA 510(k) clearance for the SERVOMED PULSE AMPLIFIER MODULE-206-. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Litton Medical Electronics (Elk Grove Village, US). The FDA issued a Cleared decision on October 29, 1984 after a review of 265 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Litton Medical Electronics devices

FDA 510(k) Submission Details - K840523

510(k) Number K840523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1984
Decision Date October 29, 1984
Days to Decision 265 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 125d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 204
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K840523.
PATIENT MONITOR 78354A
K842236 · Hewlett-Packard Co. · Jan 1985
ARRHYTHMIA CENTRAL-OGP-7201
K844911 · Nihon Kohden America, Inc. · Jan 1985
DYNASCOPE MONITOR DS-800
K844348 · Fukuda Denshi USA, Inc. · Dec 1984
DIASCOPE 2
K833689 · S & W Medico Teknik · Oct 1984
SERVOMED BASIC BEDSIDE UNIT SMV 110TP
K840524 · Litton Medical Electronics · Oct 1984
HEART RATE/RESPIRATION SIMULATOR 8310
K841363 · Aequitron Medical, Inc. · Oct 1984