Cleared Traditional

ELATEC HOLTER ANALYZER

K895806 · Ela Medical, Inc. · Cardiovascular
Apr 1990
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K895806 is an FDA 510(k) clearance for the ELATEC HOLTER ANALYZER, a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on April 4, 1990, 188 days after receiving the submission on September 28, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K895806 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1989
Decision Date April 04, 1990
Days to Decision 188 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DSI — Detector And Alarm, Arrhythmia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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