Heartlink, Model II
FDA 510(k) K982803 · Cardiac Telecom Corp.
510(k) numberK982803
Submission
- Device name
- Heartlink, Model II
- Applicant
- Cardiac Telecom Corp.
Turtle Creek, PA, US - Received
- August 10, 1998
- Decision date
- November 13, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QYX – Outpatient Cardiac Telemetry
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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 clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of…
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Questions and answers
When was Heartlink, Model II cleared by the FDA?
Heartlink, Model II (K982803) received a 510(k) decision of Substantially Equivalent on November 13, 1998, 95 days after the submission was received.
What is the product code of K982803?
The FDA product code is QYX – Outpatient Cardiac Telemetry, a Class II (moderate risk) device regulated under 21 CFR 870.1025.