Cleared Traditional

K000237 - EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION

K000237 is an FDA 510(k) clearance for EHC 400 DESKTOP PATIENT STATION, manufactured by Cybercare, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K000237 · Cybercare, Inc. · Cardiovascular device
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Jun 2000
Decision
138d
Days
Class 2
Risk

K000237 is an FDA 510(k) clearance for the EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Cybercare, Inc. (Atlanta, US). The FDA issued a Cleared decision on June 13, 2000 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Cybercare, Inc. devices

FDA 510(k) Submission Details - K000237

510(k) Number K000237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2000
Decision Date June 13, 2000
Days to Decision 138 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
13d slower than avg
Panel avg: 125d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 847
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