Cleared Traditional

K832227 - G-2000

K832227 is an FDA 510(k) clearance for G-2000, manufactured by Eaton Medical Group. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K832227 · Eaton Medical Group · Cardiovascular device
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Dec 1983
Decision
146d
Days
Class 2
Risk

K832227 is an FDA 510(k) clearance for the G-2000. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Eaton Medical Group (Mchenry, US). The FDA issued a Cleared decision on December 1, 1983 after a review of 146 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

FDA 510(k) Submission Details - K832227

510(k) Number K832227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1983
Decision Date December 01, 1983
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

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 430
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K832227.
VITAL SIGNS MONITOR 3
K833584 · Physio-Control Corp. · Jan 1984
MORTARA INSTRUMENT #101
K832050 · Mortara Instrument, Inc. · Dec 1983
MINI-PECG
K832883 · Intersect Systems, Inc. · Dec 1983
CASE-II
K833458 · Marquette Electronics, Inc. · Nov 1983
PACEMAKER EVALUATION MODULE-330
K833470 · Marquette Electronics, Inc. · Nov 1983
LME PATIENT MONITOR SMS 151
K832013 · Litton Medical Electronics · Oct 1983