Cleared Traditional

K971683 - WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET

K971683 is an FDA 510(k) clearance for WIRELESS LAN (LOCAL AREA NETWORK) - WIR..., manufactured by Marquette Electronics, Inc.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K971683 · Marquette Electronics, Inc. · Cardiovascular device
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Oct 1997
Decision
168d
Days
Class 2
Risk

K971683 is an FDA 510(k) clearance for the WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on October 22, 1997 after a review of 168 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. 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 - K971683

510(k) Number K971683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1997
Decision Date October 22, 1997
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSX Device Classification - Class 2, Special Controls

Product Code MSX System, Network And Communication, Physiological Monitors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MSX System, Network And Communication, Physiological Monitors

All 108
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K971683.
HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER
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IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM
K971868 · Marquette Electronics, Inc. · Nov 1997
(VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH
K962473 · Data Critical Corporation · Nov 1997
MDP2000 MEDICAL DATA PROCESSOR
K972880 · Vidco, Inc. · Oct 1997
DINAMAP MPS PORTABLE MONITOR
K971569 · Johnson & Johnson Medical, Inc. · Sep 1997