Cleared Traditional

K011328 - CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH (FDA 510(k) Clearance)

K011328 · Bionet Company, Ltd. · Cardiovascular device
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Nov 2001
Decision
204d
Days
-
Risk

K011328 is an FDA 510(k) clearance for the CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH.

Submitted by Bionet Company, Ltd. (Seoul, KR). The FDA issued a Cleared decision on November 21, 2001 after a review of 204 days - an extended review cycle.

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.

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Submission Details

510(k) Number K011328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2001
Decision Date November 21, 2001
Days to Decision 204 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
79d slower than avg
Panel avg: 125d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -