HEARTRAC ECG MONITORING SYSTEM— 510(k) K934913

Name: FDA 510(k) clearance K934913
Creator: U.S. Food and Drug Administration
Published: 1995-06-05

Substantially Equivalent

Cardiac Telecom Corp.

FDA 510(k) clearance K934913 for HEARTRAC ECG MONITORING SYSTEM, Substantially Equivalent on 1995-06-05. Applicant: Cardiac Telecom Corp.. Device class: 2.

Clearance details

Applicant: Cardiac Telecom Corp.
Product code: Code QYW
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 1993-10-15
Decision date: 1995-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QYW

view all

K133973 — TEMPUS PRO WITH ENHANCED FEATURES2014-08-14

More clearances from Cardiac Telecom Corp.

view all

K982803 — HEARTLINK, MODEL II1998-11-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.