Cleared Traditional

CARDIOVIT CS-200 (K970879) - FDA 510(k) Clearance

K970879 · Schiller America, Inc. · Cardiovascular device
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Jun 1997
Decision
107d
Days
-
Risk

K970879 is an FDA 510(k) clearance for the CARDIOVIT CS-200.

Submitted by Schiller America, Inc. (Tustin, US). The FDA issued a Cleared decision on June 25, 1997 after a review of 107 days - within the typical 510(k) review window.

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.

View all Schiller America, Inc. devices

Submission Details

510(k) Number K970879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1997
Decision Date June 25, 1997
Days to Decision 107 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 16
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