Cleared Traditional

K770366 - ISOLATED ELECTROCARDIOGRAPH MODEL 1207

K770366 is the FDA 510(k) clearance for ISOLATED ELECTROCARDIOGRAPH MODEL 1207 by Electronics For Medicine, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K770366 · Electronics For Medicine, Inc. · Cardiovascular device
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Mar 1977
Decision
6d
Days
Class 2
Risk

K770366 is an FDA 510(k) clearance for the ISOLATED ELECTROCARDIOGRAPH MODEL 1207. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Electronics For Medicine, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1977 after a review of 6 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 Electronics For Medicine, Inc. devices

Submission Details

510(k) Number K770366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1977
Decision Date March 01, 1977
Days to Decision 6 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 125d · This submission: 6d
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 177
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K770366.
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
LIFEPAK 5 CARDIOSCOPE MODULE (NPN 5)
K760677 · Physio-Control Corp. · Oct 1976
ELECTROCARDIOGRAPH (#1505A)
K760542 · Hewlett-Packard Co. · Sep 1976