Cleared Traditional

K934887 - 9750 ATHENA ETHERNET OPTION

K934887 is an FDA 510(k) clearance for 9750 ATHENA ETHERNET OPTION, manufactured by S & W Medico Teknik A/S. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K934887 · S & W Medico Teknik A/S · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
94d
Days
Class 2
Risk

K934887 is an FDA 510(k) clearance for the 9750 ATHENA ETHERNET OPTION. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by S & W Medico Teknik A/S (Albertslund, DK). The FDA issued a Cleared decision on January 14, 1994 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - 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 S & W Medico Teknik A/S devices

FDA 510(k) Submission Details - K934887

510(k) Number K934887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1993
Decision Date January 14, 1994
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXK Device Classification - Class 2, Special Controls

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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 - DXK Echocardiograph

All 47
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K934887.
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K160173 · Boston Scientific Corporation · Feb 2016
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MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
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PATIENT CARE MANAGEMENT SYSTEM MODIFICATION
K910029 · Spacelabs, Inc. · Jan 1991
INTERSPEC APOGEE
K903839 · Interspec, Inc. · Nov 1990