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

Submission Details

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.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 43
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K842308.
MINGOGRAF 740 - MODEL #91-54-634
K864575 · Siemens Medical Solutions USA, Inc. · May 1987
ELITE ELECTROCARDIOGRAPH
K870920 · Burdick Corp. · Apr 1987
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