Cleared Traditional

CARDIO-CARD ECG MANAGEMENT SYSTEM

K920020 · Nasiff Assoc., Inc. · Cardiovascular

Jul 1992

Decision

189d

Days

Class 2

Risk

About This 510(k) Submission

K920020 is an FDA 510(k) clearance for the CARDIO-CARD ECG MANAGEMENT SYSTEM, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Nasiff Assoc., Inc. (Brewerton, US). The FDA issued a Cleared decision on July 9, 1992, 189 days after receiving the submission on January 2, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number	K920020 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 02, 1992
Decision Date	July 09, 1992
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement