Cleared Traditional

K832998 - 2-CHANNEL RECORDER

K832998 is the FDA 510(k) clearance for 2-CHANNEL RECORDER by Litton Medical Electronics. It is a Class 1 Cardiovascular device (product code DSF) cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K832998 · Litton Medical Electronics · Cardiovascular device
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Jun 1984
Decision
288d
Days
Class 1
Risk

K832998 is an FDA 510(k) clearance for the 2-CHANNEL RECORDER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Litton Medical Electronics (Walker, US). The FDA issued a Cleared decision on June 1, 1984 after a review of 288 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2810 - 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

Submission Details

510(k) Number K832998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1983
Decision Date June 01, 1984
Days to Decision 288 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 125d · This submission: 288d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DSF Recorder, Paper Chart
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DSF Recorder, Paper Chart

All 33
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K832998.
OHMEDA MODEL 0001/0003 RECORDER
K851274 · Ohmeda Medical · May 1985
SIREDOC, PAPER CHART RECORDER
K850146 · Siemens Medical Solutions USA, Inc. · Feb 1985
THERMAL GRAYSCALE RF-100
K843836 · Fukuda Denshi USA, Inc. · Oct 1984
DUAL CHANNEL RECORDER #78574A
K830315 · Hewlett-Packard Co. · Mar 1983
MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3
K822978 · Siemens Corp. · Dec 1982
MINGOCARD 7 & MINGOPHONE 7
K822983 · Siemens Corp. · Nov 1982