510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934913Substantially Equivalent

Heartrac ECG Monitoring System

Cardiac Telecom Corp., Washington, D.C. DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934913 is the FDA 510(k) clearance record for HEARTRAC ECG MONITORING SYSTEM, a class II device, cleared for Cardiac Telecom Corp. on under FDA product code QYW (Hospital Cardiac Telemetry). FDA's definition for product code QYW reads: "Devices are intended to continuously record, display, and/or analyze electrocardiograms of patients in in a healthcare facility for detecting conditions that may require prompt intervention. They may include automatic detection and...". FDA records list 2 510(k) clearances for Cardiac Telecom Corp., from to . As of , FDA records show no recalls naming K934913.

Clearance record

Decision date
Received
(598 days to decision)
Product code
QYW Hospital Cardiac Telemetry
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiac Telecom Corp. Columbia Sq., Washington, D.C. DC
510(k) summary
Summary
Third party review
No

Clearances, product code QYW

Trailing 12 months

FDA records hold no clearances under product code QYW in the trailing twelve months.

FDA records show no clearances under product code QYW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QYW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260