Tempus Pro with Enhanced Features
FDA 510(k) K133973 · Remote Diagnostic Technologies , Ltd.
510(k) numberK133973
Submission
- Device name
- Tempus Pro with Enhanced Features
- Applicant
- Remote Diagnostic Technologies , Ltd.
Basingstoke, GB - Received
- December 26, 2013
- Decision date
- August 14, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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…
Other 510(k)s with product code QYW
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|---|---|---|---|
| K934913 | Heartrac ECG Monitoring SystemQYW · Traditional | Cardiac Telecom Corp. | 06/05/1995SE |
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Questions and answers
When was Tempus Pro with Enhanced Features cleared by the FDA?
Tempus Pro with Enhanced Features (K133973) received a 510(k) decision of Substantially Equivalent on August 14, 2014, 231 days after the submission was received.
What is the product code of K133973?
The FDA product code is QYW – Hospital Cardiac Telemetry, a Class II (moderate risk) device regulated under 21 CFR 870.1025.