Nuvant, Mobilc Cardiac Telemetry
FDA 510(k) K113372 · Corventis, Inc.
510(k) numberK113372
Submission
- Device name
- Nuvant, Mobilc Cardiac Telemetry
- Applicant
- Corventis, Inc.
St. Paul, MN, US - Received
- November 16, 2011
- Decision date
- March 7, 2012
- 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 |
| 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 |
| K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemQYX · Special | 06/19/2009SE |
| K083287 | Avivo Mobile Patient Management SystemDSI · Abbreviated | 02/03/2009SE |
Questions and answers
When was Nuvant, Mobilc Cardiac Telemetry cleared by the FDA?
Nuvant, Mobilc Cardiac Telemetry (K113372) received a 510(k) decision of Substantially Equivalent on March 7, 2012, 112 days after the submission was received.
What is the product code of K113372?
The FDA product code is QYX – Outpatient Cardiac Telemetry, a Class II (moderate risk) device regulated under 21 CFR 870.1025.