Cleared Traditional

K933143 - MODEL ELI 300 ELECTROCARDIOGRAPH (FDA 510(k) Clearance)

K933143 · Mortara Instrument, Inc. · Cardiovascular device
Apr 1994
Decision
291d
Days
-
Risk

K933143 is an FDA 510(k) clearance for the MODEL ELI 300 ELECTROCARDIOGRAPH.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on April 15, 1994 after a review of 291 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel. 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.

Submission Details

510(k) Number K933143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1993
Decision Date April 15, 1994
Days to Decision 291 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 140d · This submission: 291d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -