Cleared Traditional

K790233 - ELECTROCARDIOGRAPH, AT-300 3 CHANNEL

K790233 is an FDA 510(k) clearance for ELECTROCARDIOGRAPH, manufactured by Health Technology Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K790233 · Health Technology Laboratories, Inc. · Cardiovascular device
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Feb 1979
Decision
6d
Days
Class 2
Risk

K790233 is an FDA 510(k) clearance for the ELECTROCARDIOGRAPH, AT-300 3 CHANNEL. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Health Technology Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 8, 1979 after a review of 6 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.

FDA 510(k) Submission Details - K790233

510(k) Number K790233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1979
Decision Date February 08, 1979
Days to Decision 6 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 125d · This submission: 6d
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 579
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K790233.
25-50 EKG RULER
K790691 · Medical Engineering Designs Co., Inc. · Apr 1979
META III
K790300 · Hittman Medical Systems · Mar 1979
ELECTROCARDIOGRAPH, EK-9
K790114 · Burdick Corp. · Feb 1979
MONITOR/MINI SCOPE
K781679 · Ipco Corp. · Dec 1978
LIFELINE AMBULATORY
K781054 · Imc · Jul 1978
CARDIAC MINIGRAPH
K780307 · Arco Medical Products Co. · May 1978
K790233 · ELECTROCARDIOGRAPH, AT-300 3 CHANNEL
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