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510(k) Data Aggregation
K Number
K152107Device Name
HealthChek Network Health Station
Manufacturer
HEALTHCHEK NETWORK, LLC
Date Cleared
2016-04-12
(258 days)
Product Code
DXN, FRW
Regulation Number
870.1130Why did this record match?
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Matched: '880.2720'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HCK - 2000 (health station) is an automated system intended to be used by the general adult public, in public environments, so that the user can measure his/her own health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. For personal reference purposes, the user can also choose to print or store their data on the HealthChek network's database.
Device Description
The HealthChek Network Health Station, Model HCK - 2000 is a kiosk designed for use by the general adult public in public locations to measure the user's health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. The HealthChek Network Health Station kiosk is not a diagnostic device. It does not introduce any novel modes of operational theory.
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K Number
K142469Device Name
2D Mercy TAPE & 3D Mercy TAPE
Manufacturer
Children's Mercy Hospital
Date Cleared
2015-05-01
(240 days)
Product Code
PIR
Regulation Number
878.4800Why did this record match?
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Matched: '880.2720'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mercy TAPE device (2D and 3D models) is intended to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the Mercy TAPE device for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC).
The Mercy TAPE device may be less reliable for use in children with known or apparent limb deformities, or abnormal body proportions caused by conditions such as edema or severe malnutrition.
Device Description
The Mercy TAPE Device (2D and 3D Models) consists of semi-durable or disposable flexible strips of coated paper, fabric or plastic tape printed with numbered bins proportional to fractional body weight of pediatric patients. The markings correspond to the validated Mercy Method (calculation algorithm) for determining pediatric body weight using humeral length and mid-upper arm circumference.
The Mercy TAPE Device 2D Model consists of a single strip of tape that is used in two (2) stages to measure humeral length and mid-upper arm circumference. For the Mercy TAPE Device 3D Model, two (2) perpendicular strips of tape are designed to be joined into a sliding "T" shape so that humeral length and mid-upper arm circumference can be measured.
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K Number
K110516Device Name
CONNEX VITAL SIGNS MONITOR 6000 SERIES
Manufacturer
WELCH ALLYN, INC.
Date Cleared
2011-06-01
(98 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
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Matched: '880.2720'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VSM 6000 Series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:
- noninvasive blood pressure.
- pulse rate,
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
- body temperature in normal and axillary modes.
The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.
The optional Masimo Rainbow SET® and accessories are indicated for the continuous noninvasive monitoring of total hemoglobin concentration of adult, pediatric, and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input.
This product is available for sale only upon the order of a physician or licensed health care professional.
Device Description
The Welch Allyn Connex® Vital Signs Monitor 6000 Series is designed to provide a scalable, modular system of components that can be configured to address the needs for vital signs spot check and continuous monitoring.
The CVSM 6000 Series is intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), Total Hemoglobin (SpHb and SpHbv), and body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. The CVSM can also display and transfer patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode, IR temperature, and other patient or facility information. Data can be transferred electronically via USB, wired Ethernet, or wireless communications.
The monitor has an enclosure constructed of engineering plastics with internal steel members for strengthening. A silicone light bar is prominent in a carry handle on the top of the device and illuminates for different alarm conditions. A power button is located on the side of the device. A touch screen display is prominent on the front of the device and provides the primary interface for the user to interact with the device. Internal and external communications are primarily by USB. External host USB connections for accessories are tool accessible. A USB connection for data transfer is on the side of the device, as is a connection to an internal relay for use with nurse call systems. The device contains an internal AC power supply for operating the device and charging the internal Lithium Ion battery.
The monitor can be configured for use in different workflows including desktop, affixed to a mobile stand, or on a wall mount.
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