Cleared Traditional

MUSE CARDIOVASCULAR INFORMATION SYSTEM (K980495) - FDA 510(k) Clearance

K980495 · Marquette Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
87d
Days
-
Risk

K980495 is an FDA 510(k) clearance for the MUSE CARDIOVASCULAR INFORMATION SYSTEM.

Submitted by Marquette Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on May 7, 1998 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Marquette Medical Systems, Inc. devices

Submission Details

510(k) Number K980495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1998
Decision Date May 07, 1998
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 16
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K980495.
NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES
K984504 · Nihon Kohden America, Inc. · Apr 1999
PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA
K981265 · Hewlett-Packard Co. · Jun 1998
MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT
K974087 · Hewlett-Packard Co. · Jun 1998
NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
K961272 · Nihon Kohden America, Inc. · Nov 1996
QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH
K961014 · Quinton, Inc. · Jul 1996
PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO
K954980 · Hewlett-Packard Co. · May 1996