Cleared Traditional

CARDIO-CARD INTERPRETATION SYSTEM I

K993616 · Nasiff Assoc., Inc. · Cardiovascular

Apr 2000

Decision

167d

Days

—

Risk

About This 510(k) Submission

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, 167 days after receiving the submission on October 26, 1999. This device falls under the Cardiovascular review panel.

Submission Details

510(k) Number	K993616 FDA.gov
FDA Decision	Cleared 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