Avivo Mobile Patient Management
FDA 510(k) K113187 · Corventis, Inc.
510(k) numberK113187
Submission
- Device name
- Avivo Mobile Patient Management
- Applicant
- Corventis, Inc.
St. Paul, MN, US - Received
- October 31, 2011
- Decision date
- January 4, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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| K260579 | Infinity® Acute Care System (IACS) VG8.1MHX · Traditional | Draeger Medical Systems, Inc. | 08/20/2026SE |
| K251508 | Telemetry Monitor (iT30, iT50)MHX · Traditional | Edan Instruments, Inc. | 08/06/2026SE |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | Ge Medical Systems Information Technologies, Inc. | 07/24/2026SE |
| K254209 | Radius VSM and AccessoriesMHX · Traditional | Masimo Corporation | 06/04/2026SE |
| K252840 | M12 Telemetry SystemMHX · Traditional | Global Instrumentation, LLC | 05/29/2026SE |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C…MHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/20/2026SE |
| K250349 | Vista CMSMHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/24/2026SE |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/16/2026SE |
More from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K133701 | Nuvant MCT SystemQYX · Special | 02/06/2014SE |
| K113372 | Nuvant, Mobilc Cardiac TelemetryQYX · Special | 03/07/2012SE |
| 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 Avivo Mobile Patient Management cleared by the FDA?
Avivo Mobile Patient Management (K113187) received a 510(k) decision of Substantially Equivalent on January 4, 2012, 65 days after the submission was received.
What is the product code of K113187?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.