Cleared Traditional

K883454 - MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH

K883454 is the FDA 510(k) clearance for MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH by Cambridge Medical Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K883454 · Cambridge Medical Instruments, Inc. · Cardiovascular device
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Jan 1989
Decision
163d
Days
Class 2
Risk

K883454 is an FDA 510(k) clearance for the MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cambridge Medical Instruments, Inc. (Ossining, US). The FDA issued a Cleared decision on January 25, 1989 after a review of 163 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Cambridge Medical Instruments, Inc. devices

Submission Details

510(k) Number K883454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1988
Decision Date January 25, 1989
Days to Decision 163 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 261
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K883454.
E350 ELECTROCARDIOGRAPH
K892835 · Burdick Corp. · Jun 1989
TYPE 9040 SYSTEM ATHENA
K884116 · S & W Medico Teknik · Apr 1989
7610 COLORVIEW SLAVE SCOPE
K890481 · Marquette Electronics, Inc. · Mar 1989
EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)
K883402 · Quinton, Inc. · Jan 1989
FUKUDA DENSHI MODEL FX-1201
K884992 · Fukuda Denshi USA, Inc. · Jan 1989
Q5000 ST/HR SLOPE MODIFICATION
K883468 · Quinton, Inc. · Dec 1988