Cleared Traditional

K823584 - FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO-

K823584 is the FDA 510(k) clearance for FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO- by Brentwood Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K823584 · Brentwood Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1982
Decision
24d
Days
Class 2
Risk

K823584 is an FDA 510(k) clearance for the FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO-. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Brentwood Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on December 30, 1982 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Brentwood Instruments, Inc. devices

Submission Details

510(k) Number K823584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1982
Decision Date December 30, 1982
Days to Decision 24 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 172
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K823584.
PACEMAKER EVALUATION MODULE-330
K833470 · Marquette Electronics, Inc. · Nov 1983
PATIENT SELECTOR FUNCTION BLOCK
K832212 · Honeywell, Inc. · Oct 1983
CONVERTER UNIT FOR ECG TRACE DISPLAY
K830566 · Honeywell, Inc. · May 1983
MODEL RM 6000, 6100,6200 POLYGRAPH
K823281 · Nihon Kohden America, Inc. · Dec 1982
COSMOS
K823220 · Nihon Kohden America, Inc. · Nov 1982
QUINTON Q, SCAN MODELS 900 & 901
K821758 · Quinton, Inc. · Aug 1982