Cleared Traditional

K993616 - CARDIO-CARD INTERPRETATION SYSTEM I

K993616 · Nasiff Assoc., Inc. · Cardiovascular device
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Apr 2000
Decision
167d
Days
-
Risk

K993616 is an FDA 510(k) clearance for the CARDIO-CARD INTERPRETATION SYSTEM I.

Submitted by Nasiff Assoc., Inc. (Brewerton, US). The FDA issued a Cleared decision on April 10, 2000 after a review of 167 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.

View all Nasiff Assoc., Inc. devices

FDA 510(k) Submission Details - K993616

510(k) Number K993616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1999
Decision Date April 10, 2000
Days to Decision 167 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
42d slower than avg
Panel avg: 125d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

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