FDA 510(k) · Corventis
K091971: AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM (Corventis, Inc.)
Corventis, Inc. received FDA 510(k) K091971 for AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM, with a decision date of Aug 27, 2009 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K091971 |
|---|---|
| Pathway | 510(k) |
| Applicant | Corventis, Inc. |
| Device name | AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM |
| Product code | DSI: Detector And Alarm, Arrhythmia |
| Regulation (21 CFR) | 870.1025 |
| Device class | Class 2 |
| Date received | Jul 1, 2009 |
| Decision date | Aug 27, 2009 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Statements. 2. INDICATION FOR USE STATEMENT a. AVIVO The AVIVOTM Mobile Patient Management System is intended to continuously record, 'store, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The AVIVO Mobile Patient Management System also monitors, derives and displays: * ECG * Heart Rate (including HR variability) * Activity * Posture · Body Temperature · Respiration rate (including RR variability)
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K091971
- K113187 AVIVO MOBILE PATIENT MANAGEMENT (Corventis, Jan 4, 2012, MHX)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DSI is "Detector And Alarm, Arrhythmia", class 2, 21 CFR 870.1025.
Our labels for filtering: claim AFib / irregular rhythm, sensor ECG electrodes. These are heuristics, not FDA fields.