Zensor+ Software
Zensor+ Software is a PC viewer for physiological recordings downloaded from the Zensor monitoring device. It allows clinicians to review previously stored full disclosure ECG and event…
Zensor+ Software is a PC viewer for physiological recordings downloaded from the Zensor monitoring device. It allows clinicians to review previously stored full disclosure ECG and event data for later analysis as part of ambulatory cardiac monitoring in adults.
The monitoring device can store ECG, respiration and activity data, which are imported into Zensor+ for viewing. Acquisition takes place in the separate wearable device. The software presents the downloaded information for the clinician’s review.
Listed Item
The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens’ medical devices. The web and PC components of the software can be configured to be used individually or together. The zensor+ software allows review of all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician. The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
System Roles
Zensor+ serves retrospective review, while the separate Zensoronline web application receives transmitted events and the Zensor App configures the recorder. These components have distinct roles within the monitoring system used to provide clinicians with data from the home environment.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| General Meditech, Inc. | Shenzhen | Guangdong | Complaint-file establishment | 3 |
Record
| Listed by | Intelesens Limited, United Kingdom |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| 510(k) | K151027 |
| Record published | 2018-05-15 |
| Record revised | 2018-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PN0811 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 326 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 266 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden Corp. | 205 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden America, Inc. | 139 |
| Surveyor Central | Mortara Instrument, Inc. | 71 |
| Tempus Pro | Remote Diagnostic Technologies Ltd. | 44 |
| Surveyor S12 | Mortara Instrument, Inc. | 38 |
| Ultraview | Spacelabs Healthcare (Washington), Inc | 29 |
| Surveyor S19 | Mortara Instrument, Inc. | 26 |
| Vital Signs™ | AirLife Finland Oy | 23 |
| Patient Monitor | Edan Instruments, Inc. | 22 |
| Telemetry Accessories | Philips Medizin Systeme Böblingen GmbH | 21 |
Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153275 | 2016-02-26 |
| K151027 | 2015-10-02 |
| K110015 | 2011-05-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.