Cleared Traditional

K895232 - MODEL ELI-100/ST ELECTROCARDIOGRAPH (FDA 510(k) Clearance)

K895232 · Mortara Instrument, Inc. · Cardiovascular device
Dec 1989
Decision
114d
Days
-
Risk

K895232 is an FDA 510(k) clearance for the MODEL ELI-100/ST ELECTROCARDIOGRAPH.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on December 13, 1989 after a review of 114 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 K895232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1989
Decision Date December 13, 1989
Days to Decision 114 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 140d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -