Heartrac ECG Monitoring System
FDA 510(k) K934913 · Cardiac Telecom Corp.
510(k) numberK934913
Submission
- Device name
- Heartrac ECG Monitoring System
- Applicant
- Cardiac Telecom Corp.
Washington, D.C., DC, US - Received
- October 15, 1993
- Decision date
- June 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QYW – Hospital Cardiac Telemetry
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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…
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| K133973 | Tempus Pro with Enhanced FeaturesQYW · Abbreviated | Remote Diagnostic Technologies , Ltd. | 08/14/2014SE |
More from Remote Diagnostic Technologies , Ltd.
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| K982803 | Heartlink, Model IIQYX · Traditional | 11/13/1998SE |
Questions and answers
When was Heartrac ECG Monitoring System cleared by the FDA?
Heartrac ECG Monitoring System (K934913) received a 510(k) decision of Substantially Equivalent on June 5, 1995, 598 days after the submission was received.
What is the product code of K934913?
The FDA product code is QYW – Hospital Cardiac Telemetry, a Class II (moderate risk) device regulated under 21 CFR 870.1025.