510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982803Substantially Equivalent

Heartlink, Model II

Cardiac Telecom Corp., Turtle Creek PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982803 is the FDA 510(k) clearance record for HEARTLINK, MODEL II, a class II device, cleared for Cardiac Telecom Corp. on under FDA product code QYX (Outpatient Cardiac Telemetry). FDA's definition for product code QYX reads: "Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing...". FDA records list 2 510(k) clearances for Cardiac Telecom Corp., from to . As of , FDA records show no recalls naming K982803.

Clearance record

Decision date
Received
(95 days to decision)
Product code
QYX Outpatient Cardiac Telemetry
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiac Telecom Corp. 503 Braddock Ave., Turtle Creek PA
510(k) summary
Summary
Third party review
No

Clearances, product code QYX

Trailing 12 months
1 clearance under product code QYX in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QYX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260