Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System
FDA 510(k) K090696 · Corventis, Inc.
Submission
- Device name
- Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System
- Applicant
- Corventis, Inc.
San Jose, CA, US - Received
- March 16, 2009
- Decision date
- June 19, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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More from Infobionic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K133701 | Nuvant MCT SystemQYX · Special | 02/06/2014SE |
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| K113187 | Avivo Mobile Patient ManagementMHX · Abbreviated | 01/04/2012SE |
| K111917 | Nuvant, Mobile Cardiac TelemetryQYX · Abbreviated | 08/24/2011SE |
| K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemDSI · Special | 08/27/2009SE |
| K083287 | Avivo Mobile Patient Management SystemDSI · Abbreviated | 02/03/2009SE |
Questions and answers
When was Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System cleared by the FDA?
Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System (K090696) received a 510(k) decision of Substantially Equivalent on June 19, 2009, 95 days after the submission was received.
What is the product code of K090696?
The FDA product code is QYX – Outpatient Cardiac Telemetry, a Class II (moderate risk) device regulated under 21 CFR 870.1025.