Cleared Traditional

K002984 - EHC400 DESKTOP PATIENT STATION

Also marketed or referenced as:
EHC600 CARE PROVIDER STATION

K002984 is an FDA 510(k) clearance for EHC400 DESKTOP PATIENT STATION, manufactured by Cybercare Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K002984 · Cybercare Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
84d
Days
Class 2
Risk

K002984 is an FDA 510(k) clearance for the EHC400 DESKTOP PATIENT STATION. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Cybercare Technologies, Inc. (Atlanta, US). The FDA issued a Cleared decision on December 18, 2000 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - 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: 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 Cybercare Technologies, Inc. devices

FDA 510(k) Submission Details - K002984

510(k) Number K002984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2000
Decision Date December 18, 2000
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQD Device Classification - Class 2, Special Controls

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
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 - DQD Stethoscope, Electronic

All 94
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K002984.
MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)
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K012304 · American Diagnostic Corp. · Nov 2001
3M LITTMANN
K003723 · 3M Company · Mar 2001
GEMINI E
K993623 · Allen Medical Instruments Corp. · Jun 2000
DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00
K991714 · Doctor'S Research Group, Inc. · Dec 1999
3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE
K991756 · Bio-Research Associates, Inc. · Dec 1999