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

Hospital Cardiac Telemetry

21 CFR 870.1025 / Cardiovascular
FDA source (opens on fda.gov)

QYW is the FDA product code for Hospital Cardiac Telemetry, a class II device type, regulated under 21 CFR 870.1025. FDA's definition for this code 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 recording of cardiac electrical activity, automated detection of life-threatening...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QYW
Device name
Hospital Cardiac Telemetry
FDA definition
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 recording of cardiac electrical activity, automated detection of life-threatening arrhythmias or other relevant conditions, and/or alarm generation. Devices may allow remote access and display of electrocardiograms acquired. Devices are intended for patients who require continuous monitoring in hospitals or healthcare facilities, with onsite medical review by qualified personnel at the central monitoring/analysis station followed by immediate notification of onsite qualified medical responders. Devices may be used for patients at elevated risk of serious cardiovascular events that would require prompt intervention. Devices are intended for prescription use only.
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QYW

By decision year
2 clearances under product code QYW with a decision year between 1995 and 2014, 1995 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QYW by decision year
YearClearances
19951
20141

Applicants with the most clearances

Product code QYW
Applicants holding the most 510(k) clearances under product code QYW
ApplicantClearances
Cardiac Telecom Corp.1
Remote Diagnostic Technologies Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code