Cleared Traditional

K823904 - MODEL 515 NEO-TRAK NEONATAL MONITOR

K823904 is an FDA 510(k) clearance for MODEL 515 NEO-TRAK NEONATAL MONITOR, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K823904 · Ge Medical Systems Information Technologies · Cardiovascular device
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May 1983
Decision
148d
Days
Class 2
Risk

K823904 is an FDA 510(k) clearance for the MODEL 515 NEO-TRAK NEONATAL MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Walker, US). The FDA issued a Cleared decision on May 25, 1983 after a review of 148 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 Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K823904

510(k) Number K823904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1982
Decision Date May 25, 1983
Days to Decision 148 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
23d slower than avg
Panel avg: 125d · This submission: 148d
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 167
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K823904.
GOULD MODEL IM3000-IM3100 BATTERY POWER
K830885 · Gould, Inc. · Jun 1983
CENTRAL STATION DISPLAY/RECORDER MATRIX
K830517 · Marquette Electronics, Inc. · Jun 1983
VITAL SIGNS MONITOR 2
K830587 · Physio-Control Corp. · Jun 1983
PRESSURE FUNCTION BLOCK FOR BLOOD PRESS
K830779 · Honeywell, Inc. · May 1983
NEUROMEDICS PACETRON HEART RATE MONITOR
K823290 · Intermedics, Inc. · Dec 1982
MODEL 78534A PATIENT MONITOR
K822876 · Hewlett-Packard Co. · Oct 1982