Cleared Traditional

K951130 - CARDIOSOFT/CARDIOSYS

K951130 · Marquette Electronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
388d
Days
-
Risk

K951130 is an FDA 510(k) clearance for the CARDIOSOFT/CARDIOSYS.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on April 4, 1996 after a review of 388 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Marquette Electronics, Inc. devices

FDA 510(k) Submission Details - K951130

510(k) Number K951130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1995
Decision Date April 04, 1996
Days to Decision 388 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
263d slower than avg
Panel avg: 125d · This submission: 388d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 61
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ECLIPSE 4 ELECTROCARDIOGRAPH
K946281 · Burdick, Inc. · Apr 1996
HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INSENSITIVE PREDICITIVE INSTRUMENT (ACI-TIPT)
K951978 · Hewlett-Packard Co. · Jan 1996
CENTRA HEART STATION
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ECG FAX MODEM
K941282 · Hewlett-Packard Co. · May 1995