FDA 510(k) · Corventis
K113187: AVIVO MOBILE PATIENT MANAGEMENT (Corventis, Inc.)
Corventis, Inc. received FDA 510(k) K113187 for AVIVO MOBILE PATIENT MANAGEMENT, with a decision date of Jan 4, 2012 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K113187 |
|---|---|
| Pathway | 510(k) |
| Applicant | Corventis, Inc. |
| Device name | AVIVO MOBILE PATIENT MANAGEMENT |
| Product code | MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Regulation (21 CFR) | 870.1025 |
| Device class | Class 2 |
| Date received | Oct 31, 2011 |
| Decision date | Jan 4, 2012 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Abbreviated |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Predicate ZOE (K(042113) SUMAR OFPROMC ETN The subject and predicate AVIVO and predicate NUVANT meet the requirements of following performance standards in accordance with FDA C/ass /Special Controls Guidance Document: Arrhythmia Detector and Alarm. Section 7:
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 K113187
- K153160 AVIVO Mobile Patient Management (MPM) System (Medtronic, Mar 30, 2016, 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 MHX is "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", class 2, 21 CFR 870.1025.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.