Cleared Traditional

K980495 - MUSE CARDIOVASCULAR INFORMATION SYSTEM (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 -