Cleared Traditional

K920377 - MORTARA INSTRUMENT MODEL ECG PREVU

K920377 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (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.

View all Mortara Instrument, Inc. devices

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
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.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 38
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MODEL ELI 200 ELECTROCARDIOGRAPH
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MODEL ELI 100 ELECTROCARDIOGRAPH
K920627 · Mortara Instrument, Inc. · Sep 1992
LIKEPAK 11 CARDIAC MONIT/LIFENET RS100 REC STATION
K912189 · Physio-Control Corp. · Feb 1992
SERIES 1500 12-LEAD ANALYSIS OPTION
K903644 · Marquette Electronics, Inc. · Dec 1991
FUKUDA DENSHI MODEL FCP-4101
K913811 · Fukuda Denshi USA, Inc. · Dec 1991