Cleared Traditional

K920377 - MORTARA INSTRUMENT MODEL ECG PREVU

K920377 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K920377

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 80
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K920377 · MORTARA INSTRUMENT MODEL ECG PREVU
Download PDF FDA Summary Mortara Instrument, I…