Cleared Traditional

K920377 - MORTARA INSTRUMENT MODEL ECG PREVU (FDA 510(k) Clearance)

K920377 · Mortara Instrument, Inc. · Cardiovascular device
Apr 1992
Decision
90d
Days
-
Risk

K920377 is an FDA 510(k) clearance for the MORTARA INSTRUMENT MODEL ECG PREVU.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on April 28, 1992 after a review of 90 days - within the typical 510(k) review window.

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 K920377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1992
Decision Date April 28, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -