Cleared Traditional

K843376 - ECG PATIENT MONITOR

K843376 is an FDA 510(k) clearance for ECG PATIENT MONITOR, manufactured by Rigel Medical Electronics, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K843376 · Rigel Medical Electronics, Inc. · Cardiovascular device
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Dec 1984
Decision
121d
Days
Class 2
Risk

K843376 is an FDA 510(k) clearance for the ECG PATIENT MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Rigel Medical Electronics, Inc. (Mill Valley, US). The FDA issued a Cleared decision on December 27, 1984 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Rigel Medical Electronics, Inc. devices

FDA 510(k) Submission Details - K843376

510(k) Number K843376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1984
Decision Date December 27, 1984
Days to Decision 121 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 227
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K843376.
SPACELABS SERIES 600 PATIENT MONITORS
K844888 · Spacelabs, Inc. · Feb 1985
PATIENT MONITOR 78354A
K842236 · Hewlett-Packard Co. · Jan 1985
ARRHYTHMIA CENTRAL-OGP-7201
K844911 · Nihon Kohden America, Inc. · Jan 1985
DYNASCOPE MONITOR DS-800
K844348 · Fukuda Denshi USA, Inc. · Dec 1984
SERVOMED PULSE AMPLIFIER MODULE-206-
K840523 · Litton Medical Electronics · Oct 1984
DIASCOPE 2
K833689 · S & W Medico Teknik · Oct 1984