Cleared Traditional

12SSL ECG ANALYSIS PROG.(SCALER LEAD) (K802369) - FDA 510(k) Clearance

K802369 · Marquette Electronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1980
Decision
44d
Days
-
Risk

K802369 is an FDA 510(k) clearance for the 12SSL ECG ANALYSIS PROG.(SCALER LEAD).

Submitted by Marquette Electronics, Inc. (Walker, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 44 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 Electronics, Inc. devices

Submission Details

510(k) Number K802369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1980
Decision Date November 12, 1980
Days to Decision 44 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 125d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -