Cleared Traditional

MICROMED QRS CARD

K903722 · Nasiff Assoc., Inc. · Cardiovascular
Dec 1990
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K903722 is an FDA 510(k) clearance for the MICROMED QRS CARD, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Nasiff Assoc., Inc. (Brewerton, US). The FDA issued a Cleared decision on December 5, 1990, 112 days after receiving the submission on August 15, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K903722 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 1990
Decision Date December 05, 1990
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340