Cleared Traditional

K840358 - IMPEDANCE/8200 MONITOR-MODEL 8300 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K840358 · Aequitron Medical, Inc. · Cardiovascular device
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Oct 1984
Decision
278d
Days
Class 2
Risk

K840358 is an FDA 510(k) clearance for the IMPEDANCE/8200 MONITOR-MODEL 8300. Classified as Tester, Electrode, Surface, Electrocardiographic (product code KRC), Class II - Special Controls.

Submitted by Aequitron Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 30, 1984 after a review of 278 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2370 - 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 Aequitron Medical, Inc. devices

Submission Details

510(k) Number K840358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1984
Decision Date October 30, 1984
Days to Decision 278 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 125d · This submission: 278d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRC Tester, Electrode, Surface, Electrocardiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2370
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.