Cleared Traditional

K871993 - MC 6000 MULTI-CHANNEL ELECTROCARDIOGRAPH

K871993 is an FDA 510(k) clearance for MC 6000 MULTI-CHANNEL ELECTROCARDIOGRAPH, manufactured by Cambridge Medical Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K871993 · Cambridge Medical Instruments, Inc. · Cardiovascular device
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Nov 1987
Decision
181d
Days
Class 2
Risk

K871993 is an FDA 510(k) clearance for the MC 6000 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 November 23, 1987 after a review of 181 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

FDA 510(k) Submission Details - K871993

510(k) Number K871993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1987
Decision Date November 23, 1987
Days to Decision 181 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 125d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

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 430
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K871993.
FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR
K875057 · Fukuda Denshi USA, Inc. · Mar 1988
MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPH
K872658 · Del Mar Avionics · Jan 1988
FITNESS RECUMBENT ERGOMETER, MODEL FT1400
K872548 · Invacare Corp. · Dec 1987
MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR
K873584 · Quinton, Inc. · Oct 1987
MODEL 2240 SLAVE SCOPE
K873346 · Marquette Electronics, Inc. · Oct 1987
ACUSON PHYSIOLOGICAL CONTROL MODULE
K871239 · Acuson Computed Sonography · Jun 1987