Cleared Traditional

K933143 - MODEL ELI 300 ELECTROCARDIOGRAPH

K933143 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (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.

View all Mortara Instrument, Inc. devices

Submission Details

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.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 38
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K933143.
CENTRA HEART STATION
K935589 · Marquette Electronics, Inc. · Aug 1995
ECG FAX MODEM
K941282 · Hewlett-Packard Co. · May 1995
HP M177XA CARDIOGRAPHS
K935772 · Hewlett-Packard Co. · Jul 1994
CARDIOFAX Q ECG-8420A
K922394 · Nihon Kohden America, Inc. · Mar 1994
SPACE LABS MODEL 90560
K923788 · Spacelabs, Inc. · Dec 1993
MARQUETTE SL SERIES TRANSPORT REMOTE ACQUISITION
K921669 · Marquette Electronics, Inc. · May 1993