Cleared Traditional

K920626 - MODEL ELI 200 ELECTROCARDIOGRAPH

K920626 · Mortara Instrument, Inc. · Cardiovascular device
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Sep 1992
Decision
219d
Days
-
Risk

K920626 is an FDA 510(k) clearance for the MODEL ELI 200 ELECTROCARDIOGRAPH.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on September 4, 1992 after a review of 219 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 - K920626

510(k) Number K920626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1992
Decision Date September 04, 1992
Days to Decision 219 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 125d · This submission: 219d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 80
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K920626.
CARDIOVIT CS-100
K914970 · Schiller America, Inc. · Nov 1992
INTERP-1000
K921476 · Qmed, Inc. · Oct 1992
ELITE II ELECTROCARDIOGRAPH,MODIFIED
K915327 · Siemens Burdick, Inc. · Oct 1992
MODEL ELI 100 ELECTROCARDIOGRAPH
K920627 · Mortara Instrument, Inc. · Sep 1992
SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM
K920294 · Stuart Medical, Inc. · Jul 1992
MEGACART
K915225 · Siemens Burdick, Inc. · Jul 1992
K920626 · MODEL ELI 200 ELECTROCARDIOGRAPH
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