Cleared Traditional

CARDIO-CARD INTERPRETATION SYSTEM I (K993616) - FDA 510(k) Clearance

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

Submission Details

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.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 82
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K993616.
PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA
K981265 · Hewlett-Packard Co. · Jun 1998
MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT
K974087 · Hewlett-Packard Co. · Jun 1998
PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO
K954980 · Hewlett-Packard Co. · May 1996
HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INSENSITIVE PREDICITIVE INSTRUMENT (ACI-TIPT)
K951978 · Hewlett-Packard Co. · Jan 1996
ECG FAX MODEM
K941282 · Hewlett-Packard Co. · May 1995
HP M177XA CARDIOGRAPHS
K935772 · Hewlett-Packard Co. · Jul 1994