Cleared Traditional

K880971 - DIGITAL MEDICINE ECG MONITOR AND RECORDER

K880971 is an FDA 510(k) clearance for DIGITAL MEDICINE ECG MONITOR AND RECORDER, manufactured by Digital Medicine Systems. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K880971 · Digital Medicine Systems · Cardiovascular device
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Aug 1988
Decision
175d
Days
Class 2
Risk

K880971 is an FDA 510(k) clearance for the DIGITAL MEDICINE ECG MONITOR AND RECORDER. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Digital Medicine Systems (Cambridge, US). The FDA issued a Cleared decision on August 30, 1988 after a review of 175 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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 Digital Medicine Systems devices

FDA 510(k) Submission Details - K880971

510(k) Number K880971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1988
Decision Date August 30, 1988
Days to Decision 175 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 197
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K880971.
M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
K894277 · Hewlett-Packard Co. · Sep 1989
MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER
K894140 · Medtronic Vascular · Jul 1989
OXINET N-7500 PULSE OXIMETRY NETWORK
K884142 · Nellcor, Inc. · Dec 1988
CARD GUARD, MODEL CG-2000
K882290 · Card Guard Scientific Survival , Ltd. · Jul 1988
ESCORT - PORTABLE PATIENT MONITOR
K881986 · Medical Data Electronics · Jul 1988
KING OF HEARTS
K880626 · Instromedix, Inc. · Apr 1988