Cleared Traditional

CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM

K960544 · Nasiff Assoc., Inc. · Cardiovascular
Aug 1996
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K960544 is an FDA 510(k) clearance for the CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM, a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT), submitted by Nasiff Assoc., Inc. (Brewerton, US). The FDA issued a Cleared decision on August 7, 1996, 182 days after receiving the submission on February 7, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K960544 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 1996
Decision Date August 07, 1996
Days to Decision 182 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DRT — Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2300

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