EK-VIEW(TM) ECG MANAGEMENT SYSTEM— 510(k) K946115

Name: FDA 510(k) clearance K946115
Creator: U.S. Food and Drug Administration
Published: 1995-03-01

Substantially Equivalent

Apcot Medical Systems

FDA 510(k) clearance K946115 for EK-VIEW(TM) ECG MANAGEMENT SYSTEM, Substantially Equivalent on 1995-03-01. Applicant: Apcot Medical Systems. Device class: 2.

Clearance details

Applicant: Apcot Medical Systems
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1994-12-15
Decision date: 1995-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

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