Cleared Traditional

K842308 - 12SSL-SC

K842308 · Marquette Electronics, Inc. · Cardiovascular device
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Sep 1984
Decision
101d
Days
-
Risk

K842308 is an FDA 510(k) clearance for the 12SSL-SC.

Submitted by Marquette Electronics, Inc. (Walker, US). The FDA issued a Cleared decision on September 21, 1984 after a review of 101 days - within the typical 510(k) review window.

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.

View all Marquette Electronics, Inc. devices

FDA 510(k) Submission Details - K842308

510(k) Number K842308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1984
Decision Date September 21, 1984
Days to Decision 101 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 125d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 61
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K842308.
ELITE ELECTROCARDIOGRAPH
K870920 · Burdick Corp. · Apr 1987
CARDIO ANALYZER MODEL 380
K844104 · Birtcher Corp. · Mar 1985
N-CHANNEL
K834212 · Philips Medical Systems (Cleveland), Inc. · Nov 1984
MARQUETTE OPTION II ECG ANALYSIS COMPUT
K820885 · Marquette Electronics, Inc. · Apr 1982
12SSL ECG ANALYSIS PROG.(SCALER LEAD)
K802369 · Marquette Electronics, Inc. · Nov 1980