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510(k) Data Aggregation
K Number
K122763Device Name
PHYSIOLOGICAL DATA PROCESSOR
Manufacturer
ZEPHYR TECHNOLOGY CORPORATION
Date Cleared
2013-06-20
(283 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
ZEPHYR TECHNOLOGY CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Packet Decoder Process (PDP) is indicated for use as a prescription software device to receive MDDS digital data packets and decode, collate and deliver data to a Class I, MDDS, Enterprise Service Bus according to a proprietary scheme defined by Zephyr Technology.
Device Description
The Packet Decoder Process (PDP) receives digital data that is transmitted by BioHarness 3.0, K 1 1 3045 in a proprietary structure. PDP receives this complex array of packet coded data. A decoding scheme is used to decode data and organize for presentation and access by Class I MDDS devices. The Packet Decoder Process is manufactured by Zephyr Technology Corporation. This software is loaded and executed in an MDDS operating systems in an MDDS computer. This complex process is defined by a proprietary scheme: Zephyr's General Comms Link Specification.
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K Number
K123658Device Name
BIOMODULE 3-M1
Manufacturer
ZEPHYR TECHNOLOGY CORPORATION
Date Cleared
2013-04-24
(147 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
ZEPHYR TECHNOLOGY CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioModule 3-M1 is a physiological monitoring telemetry device intended for monitoring ambulatory patients in alternate care settings. The device consists of adhesive electrodes and an electronics module. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. The BioModule 3-M1 provides a facility to detect and transmit single lead ECG signals to be received by qualified instruments.
The BioModule 3-M1 collects and transmits measurements captured in alternate care settings as prescribed by the health care professional. Breathing rate values are accurately transmitted only during sedentary periods.
The BioModule 3-M1 is indicated for use as a general patient monitor to provide physiological information as part of general ward monitoring system.
Device Description
The BioModule 3-M1, a physiological sensor / transmitter is composed of:
- proprietary hardware and firmware, enclosed in
- a user case (puck) with a re-chargeable battery. .
- . a adhesive electrode set and
- A cradle (to recharge battery and transfer internally stored date to an ancillary computer).
The BioModule 3-M1 is a physiological transmitter manufactured by Zephyr Technology Corporation with disposable, off the shelf electrodes that transmits data to a qualified receiving station. The BioModule 3-M1 is positioned against the patient's skin with light pressure then pressed to adhere.
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K Number
K113045Device Name
BIOHARNESS
Manufacturer
ZEPHYR TECHNOLOGY CORPORATION
Date Cleared
2012-08-14
(306 days)
Product Code
MHX, DRX
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
ZEPHYR TECHNOLOGY CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioHarness 3.0 is a physiological monitoring telemetry device intended for monitoring of adults in the home, workplace and alternate care settings. The device consists of a chest strap and an electronics module that attaches to the strap. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. The BioHarness 3.0 provides a facility to detect and transmit single lead ECG signals to be received by Bluetooth / USB qualified ECG instruments.
The BioHarness 3.0 collects and transmits measurements captured during both sedentary as well as rigorous activity for Heart Rate, Posture and Activity. Breathing rate values are accurately transmitted only during sedentary periods.
The BioHarness 3.0 is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, for general research and performance measurement purposes, or where prescribed by a healthcare professional.
The intended use of the BioHarness 3.0 is to provide a facility in the home, workplace and alternate care settings for detecting, storing and transmitting Adult - single lead ECG data to third party ECG instruments for interpretation by qualified persons. The BioHarness 3.0 stores over 140 hours of ECG signals for transmission via USB or real time Bluetooth. The scientific concept on which this device is based is the principle that low level electrical pulses from the heart are measurable of the surface of the skin. This device functions by capturing these electrical pulses via electrodes and delivering these signals to sophisticated electronics for signal processing. The calibration is established by the factory and yields accurate and calibrated signals that can maintain calibration over its useful life.
Device Description
The BioHarness 3.0, a cardiographic electrode transmitter is composed of:
- proprietary hardware and firmware, enclosed in
- a user case (puck) with a re-chargeable battery,
- various sensors embedded in a reusable chest harness, and
- ECG detection and transmission and.
- A cradle (to recharge battery and transfer internally stored date to an ancillary computer).
The BioHarness 3.0 is a physiological / cardiographic electrode transmitter manufactured by Zephyr Technology Corporation with reusable electrodes in a chest harness consisting of an electrode assembly, an elastic chest belt, and an electronics package containing a Bluetooth transmitter. The BioHarness 3.0 electrodes are positioned against the patient's skin with light pressure, using the elastic chest belt. The BioHarness 3.0 is designed to be used without electrolytic gels and without adhesives on unprepared skin: that is without the requirements for shaving, abrading, or other skin preparation. This device transmits ECG information to a compatible Bluetooth - enabled device. This transmitter is a class I Bluetooth radio with a range of approximately 100 meters (spherical range).
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K Number
K100040Device Name
BIOHARNESS
Manufacturer
ZEPHYR TECHNOLOGY CORPORATION
Date Cleared
2010-12-03
(330 days)
Product Code
MHX
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
ZEPHYR TECHNOLOGY CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioHarness is a physiological monitoring telemetry device intended for monitoring of adults in the home, workplace and alternate care settings. The device consists of a chest strap and an electronics module that attaches to the strap. The device stores and transmits vital sign data including heart rate, respiration rate, thoracic skin temperature, body orientation and activity.
The BioHarness collects and transmits measurements captured during both sedentary as well as rigorous activity for Heart Rate, Skin Temperature, Posture and Activity. Breathing rate values are accurately transmitted only during sedentary periods.
The BioHarness is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, and for general research and performance measurement purposes.
Device Description
The BioHarness is a compact physiological monitor that consists of two components:
1. A chest strap with conductive fabric skin electrodes and a thoracic expansion sensor.
2. A battery-powered electronics module that attaches to the chest strap.
The device provides both storage and real-time transmission of the user's Heart Rate, Respiration Rate, Temperature, Posture and Activity Level. The device uses heart electrical activity signals and respiratory breathing frequency inferred from thoracic movement to derive the Heart Rate and Respiration Rate respectively.
An accessory cradle is provided to recharge the internal battery and transfer internally stored data to a computer.
The transmitted data provided by the device over Bluetooth may be integrated into third party monitoring applications. A simple software utility that displays vital sign data is provided. Users may transmit vital sign data from the BioHarness to the application on a PC via Bluetooth using the Bluetooth adapter.
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