Cleared Traditional

K842976 - BRENTWOOD EZ SCAN 200 AMBULATORY ECG

K842976 is an FDA 510(k) clearance for BRENTWOOD EZ SCAN 200 AMBULATORY ECG, manufactured by Brentwood Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K842976 · Brentwood Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
214d
Days
Class 2
Risk

K842976 is an FDA 510(k) clearance for the BRENTWOOD EZ SCAN 200 AMBULATORY ECG. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Brentwood Instruments, Inc. (Torrance, US). The FDA issued a Cleared decision on March 1, 1985 after a review of 214 days - an extended review cycle.

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 Brentwood Instruments, Inc. devices

FDA 510(k) Submission Details - K842976

510(k) Number K842976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1984
Decision Date March 01, 1985
Days to Decision 214 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
89d slower than avg
Panel avg: 125d · This submission: 214d
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 270
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K842976.
OXFORD VDT-40 DISPLAY TERMINAL
K852207 · Oxford Medilog, Inc. · Jun 1985
SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A
K844791 · Analogic Corp. · Apr 1985
FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES
K850897 · Fukuda Denshi USA, Inc. · Apr 1985
ARRHYTHMIA SYSTEM AC-11
K841084 · Fukuda Denshi USA, Inc. · Feb 1985
HORIZON ECG SYSTEM
K823844 · Beckman Instruments, Inc. · Jan 1985
SERVOMED ARRHYCOMP CENTRAL MONITOR SYS
K840899 · Litton Medical Electronics · Nov 1984