Cleared Traditional

MODEL 3044 3-CHANNEL STRESS TEST SYSTEM (K761198) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K761198 · Cambridge Instruments, Inc. · Cardiovascular device
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Dec 1976
Decision
3d
Days
Class 2
Risk

K761198 is an FDA 510(k) clearance for the MODEL 3044 3-CHANNEL STRESS TEST SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cambridge Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 9, 1976 after a review of 3 days - a notably fast clearance 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: 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 Cambridge Instruments, Inc. devices

Submission Details

510(k) Number K761198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1976
Decision Date December 09, 1976
Days to Decision 3 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 125d · This submission: 3d
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 81
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K761198.
MODEL 78501A PATIENT MONITORING SYSTEM
K790939 · Hewlett-Packard Co. · Jun 1979
ELAPSED TIME INDICATOR MODEL 21361A
K771380 · Hewlett-Packard Co. · Nov 1977
MONITOR, PORTABLE, PATIENT, G.E.
K770760 · General Electric Co. · May 1977
ELECTROCARDIOGRAPH (#1505A)
K760542 · Hewlett-Packard Co. · Sep 1976
STRESS SYSTEM, SINGLE-CHANNEL (#21125)
K760463 · Hewlett-Packard Co. · Aug 1976
STRESS SYSTEM, 3-CHANNEL (#21127A)
K760465 · Hewlett-Packard Co. · Aug 1976