Cleared Traditional

K933143 - MODEL ELI 300 ELECTROCARDIOGRAPH

K933143 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K933143

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 125d · This submission: 291d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 80
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K933143 · MODEL ELI 300 ELECTROCARDIOGRAPH
Download PDF FDA Summary Mortara Instrument, I…