Cleared Traditional

MONITOR, PORTABLE, PATIENT, G.E. (K770760) - FDA 510(k) Clearance

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

K770760 · General Electric Co. · Cardiovascular device
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May 1977
Decision
11d
Days
Class 2
Risk

K770760 is an FDA 510(k) clearance for the MONITOR, PORTABLE, PATIENT, G.E.. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on May 6, 1977 after a review of 11 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 General Electric Co. devices

Submission Details

510(k) Number K770760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1977
Decision Date May 06, 1977
Days to Decision 11 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 125d · This submission: 11d
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 80
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K770760.
MODEL 4700A ELECTROCARDIOGRAPH
K802718 · Hewlett-Packard Co. · Nov 1980
MODEL 78501A PATIENT MONITORING SYSTEM
K790939 · Hewlett-Packard Co. · Jun 1979
ELAPSED TIME INDICATOR MODEL 21361A
K771380 · Hewlett-Packard Co. · Nov 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