Cleared Traditional

K830566 - CONVERTER UNIT FOR ECG TRACE DISPLAY

K830566 is an FDA 510(k) clearance for CONVERTER UNIT FOR ECG TRACE DISPLAY, manufactured by Honeywell, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K830566 · Honeywell, Inc. · Cardiovascular device
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May 1983
Decision
91d
Days
Class 2
Risk

K830566 is an FDA 510(k) clearance for the CONVERTER UNIT FOR ECG TRACE DISPLAY. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Honeywell, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1983 after a review of 91 days - within the typical 510(k) review window.

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: 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 Honeywell, Inc. devices

FDA 510(k) Submission Details - K830566

510(k) Number K830566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1983
Decision Date May 25, 1983
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

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 279
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K830566.
SIMPLISCRIPTOR EK 31/101 037 16
K832184 · Litton Medical Electronics · Oct 1983
AS 191 ECG TELEMETRY MODULE
K831429 · Narco Scientific · Oct 1983
PATIENT SELECTOR FUNCTION BLOCK
K832212 · Honeywell, Inc. · Oct 1983
ELECTROCARDIOGRAPH #334
K823488 · Birtcher Corp. · Dec 1982
MODEL RM 6000, 6100,6200 POLYGRAPH
K823281 · Nihon Kohden America, Inc. · Dec 1982
FULL-DISCLOSURE AMBULATORY ECG SYSTEM
K823529 · Clinical Data, Inc. · Dec 1982