Cleared Traditional

K834397 - HOLTER CARDIOGRAPHY SYS 6201

K834397 is an FDA 510(k) clearance for HOLTER CARDIOGRAPHY SYS 6201, manufactured by Instruments For Cardiac Research. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K834397 · Instruments For Cardiac Research · Cardiovascular device
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Apr 1984
Decision
125d
Days
Class 2
Risk

K834397 is an FDA 510(k) clearance for the HOLTER CARDIOGRAPHY SYS 6201. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Instruments For Cardiac Research (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Instruments For Cardiac Research devices

FDA 510(k) Submission Details - K834397

510(k) Number K834397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1983
Decision Date April 17, 1984
Days to Decision 125 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 125d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 315
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K834397.
LIFESCOPE 6 OEC-6201
K841500 · Nihon Kohden America, Inc. · Aug 1984
CARDIO EXPRESS 100 HOLTER SCANNER
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LEAP FROG
K834211 · Philips Medical Systems (Cleveland), Inc. · Jun 1984
ALPHA MASS STORAGE CARDULE 1895
K834597 · Spacelabs, Inc. · Apr 1984
AMBULATORY MONITORING DEVICE
K833162 · Oxford Medilog, Inc. · Jan 1984
ARRHYTHMIA III CARDULE #1919
K832693 · Spacelabs, Inc. · Nov 1983