Cleared Traditional

K830899 - THREE CHANNEL MONITOR SERIES 6700

K830899 is the FDA 510(k) clearance for THREE CHANNEL MONITOR SERIES 6700 by Marquette Electronics, Inc.. It is a Class 2 Cardiovascular device (product code DXJ) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K830899 · Marquette Electronics, Inc. · Cardiovascular device
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Apr 1983
Decision
22d
Days
Class 2
Risk

K830899 is an FDA 510(k) clearance for the THREE CHANNEL MONITOR SERIES 6700. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1983 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2450 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Marquette Electronics, Inc. devices

Submission Details

510(k) Number K830899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1983
Decision Date April 12, 1983
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
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 - DXJ Display, Cathode-ray Tube, Medical

All 56
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K830899.
SERVOMED BASIC BEDSIDE UNIT SMV 107
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SINGLE CHANNEL NONFADE OSCILLOSCOPE
K822517 · Quinton, Inc. · Sep 1982
SINGLE CHANNEL NON-FADE OSCILLOSCOPE
K811911 · Quinton, Inc. · Jul 1981
VC 430 VIDEO CONVERTER
K810164 · Honeywell, Inc. · Feb 1981