Cleared Traditional

ELECTROCARDIOGRAPH, EK-7 (3-CHANNELS) (K760271) - FDA 510(k) Clearance

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

K760271 · Burdick Corp. · Cardiovascular device
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Nov 1976
Decision
116d
Days
Class 2
Risk

K760271 is an FDA 510(k) clearance for the ELECTROCARDIOGRAPH, EK-7 (3-CHANNELS). Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Burdick Corp. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1976 after a review of 116 days - within the typical 510(k) review window.

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 Burdick Corp. devices

Submission Details

510(k) Number K760271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1976
Decision Date November 15, 1976
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
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 122
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K760271.
STRESS TEST SYSTEM
K780166 · Quinton, Inc. · Feb 1978
ELAPSED TIME INDICATOR MODEL 21361A
K771380 · Hewlett-Packard Co. · Nov 1977
MONITOR, PORTABLE, PATIENT, G.E.
K770760 · General Electric Co. · May 1977
THREE-CHANNEL STRESS TEST SYSTEM (M633)
K760854 · Quinton, Inc. · Nov 1976
ELECTROCARDIOGRAPH (#1505A)
K760542 · Hewlett-Packard Co. · Sep 1976
STRESS SYSTEM, SINGLE-CHANNEL (#21125)
K760463 · Hewlett-Packard Co. · Aug 1976