Cleared Traditional

K850322 - RESTING ECG SOFTWARE FRO G-2000 ELECTRO...

K850322 is the FDA 510(k) clearance for RESTING ECG SOFTWARE FRO G-2000 ELECTRO... by Eaton Medical Group. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K850322 · Eaton Medical Group · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
108d
Days
Class 2
Risk

K850322 is an FDA 510(k) clearance for the RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Eaton Medical Group (Eaton, US). The FDA issued a Cleared decision on May 16, 1985 after a review of 108 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 Eaton Medical Group devices

Submission Details

510(k) Number K850322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1985
Decision Date May 16, 1985
Days to Decision 108 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
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 261
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K850322.
CARDIOFAX ECG-6353
K860212 · Nihon Kohden America, Inc. · Apr 1986
VSM-5
K852322 · Physio-Control Corp. · Sep 1985
CARDIOSTAT 3 RECORDER
K851044 · Siemens Elema AB · Jun 1985
CARDIOSTAT 1 ECG RECORDER
K844392 · Siemens Elema AB · Apr 1985
MONITORING SYSTEM M720
K842944 · Burdick Corp. · Mar 1985
SURGICAL MODULE 7000 ECG
K840869 · Marquette Electronics, Inc. · Feb 1985