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510(k) Data Aggregation
K Number
K983572Device Name
SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500
Manufacturer
HEALTHDYNE TECHNOLOGIES, INC.
Date Cleared
1999-03-19
(157 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
HEALTHDYNE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Simon™ is a multichannel recording system designed to record and store physiological signals acquired from adult and pediatric patients during sleep. The portable design of the device facilitates its use in any clinical setting or in the home environment.
Physiological signals are acquired via transducers attached to the patient and directly connected to the recorder. Additionally, a modem may be used to connect to the Host PC during acquisition, to interface with a Respironics CPAP or BiPAP device for titration or to download the data post acquisition. Once downloaded, the recorded data can be scored for physiological events using the associated Simon™ HOST Software.
The clinician can review, validate, edit and print scored data. The software allows the user to configure / customize all reports to best meet individual needs.
Device Description
Simon™ is a multichannel recording system, which may be used for adult or pediatric patients in a variety of settings. The system is comprised of the Simon Recorder, Host Software, auxiliary CPAP / BiPAP devices (as applicable), computer equipment (CPU and monitor) and various accessories (modem, etc.). The recorder is small, lightweight and may be worn while the patient sleeps. The recorder collects physiologic signals from sensors attached to the patient. This eight-channel system records Nasal Flow or Pressure, Body Position, Snoring Sounds, Oximetry, Respiration via Chest Effort, Respiration via Abdominal Effort, Actigraphy, Pressure and Flow from auxiliary Respironics CPAP / BiPAP devices.
The Simon™ Host Software is a Windows-based application, which facilitates remote titration of CPAP / BiPAP settings via modem, as well as download of recorded data onto a personal computer. Once downloaded, the Host software scores the recorded data for physiological events per user-defined parameters.
The software allows user validation/editing of all events, and provides reporting capabilities that are fully user-configurable.
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K Number
K974453Device Name
NASAL INTERFACE MODEL 7910
Manufacturer
HEALTHDYNE TECHNOLOGIES, INC.
Date Cleared
1998-08-04
(252 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
HEALTHDYNE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nasal Interface is intended for use with nasal CPAP and bilevel devices for the treatment of adult patients with Obstructive Sleep Apnea. The Nasal Interface may be used in the home, hospital, nursing home, sub-acute care center or other location where nasal CPAP or bilevel therapy is applied. The Nasal Interface will facilitate nasal CPAP or bilevel therapy via a silicone seal which makes contact solely with the patient's nose on the external aspects of the nares. This device is further supported by padded protuberances, which rest on the patient's cheeks below the zygomatic processes. The device is held in place with headgear, which extends back from the nasal interface around the back and top of the patient's head.
Device Description
Nasal Interface
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K Number
K974879Device Name
MODEL 7410 VOYAGER
Manufacturer
HEALTHDYNE TECHNOLOGIES, INC.
Date Cleared
1998-06-29
(181 days)
Product Code
BZD, MAR
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
HEALTHDYNE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Model 7410 series CPAP system is a device that is intended to provide continuous positive airway pressure to adults who experience obstructive sleep apnea (OSA). The device will automatically adjust and maintain airway pressure based on the continuing needs of the patient. The device may be used in either the home or hospital environment.
Device Description
Model 7410 Series CPAP System
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K Number
K972614Device Name
TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605
Manufacturer
HEALTHDYNE TECHNOLOGIES, INC.
Date Cleared
1998-01-20
(190 days)
Product Code
CAW, DEC
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
HEALTHDYNE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Twister Oxygen Concentrator is intended to provide oxygen to persons requiring low flow oxygen therapy. This device is not intended to be life supporting nor life sustaining.
Device Description
The Twister produces concentrated oxygen from room air for delivery to a patient requiring low flow oxygen therapy. The oxygen from the air is concentrated using a molecular sieve and a pressure swing adsorption process.
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K Number
K971867Device Name
ALICE 4R SYSTEM
Manufacturer
HEALTHDYNE TECHNOLOGIES, INC.
Date Cleared
1997-08-13
(85 days)
Product Code
OLV
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
HEALTHDYNE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alice® 4 System is a polysomnographic system that is intended to record, display, and print EEG and other physiological information to clinicians/physicians. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adult or infant patients require the documentation of various sleep or other physiological disorders.
Device Description
polysomnographic system that is intended to record, display, and print EEG and other physiological information
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K Number
K971545Device Name
PROTEGE LIQUID OXYGEN SYSTEM
Manufacturer
HEALTHDYNE TECHNOLOGIES, INC.
Date Cleared
1997-07-25
(88 days)
Product Code
BYJ
Regulation Number
868.5655Why did this record match?
Applicant Name (Manufacturer) :
HEALTHDYNE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for the liquid oxygen system is to provide supplementury oxygen at a prescribed flow rate to patients with lung disorders such as COPD (Chronic Obstructive Pulmonary Disease) or other conditions as prescribed by a physician.
Device Description
Portable Liquid Oxygen System BYJ
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K Number
K970173Device Name
MODEL 1700 TRANQUILITY BILEVEL SYSTEM
Manufacturer
HEALTHDYNE TECHNOLOGIES, INC.
Date Cleared
1997-04-16
(90 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
HEALTHDYNE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K962517Device Name
MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV
Manufacturer
HEALTHDYNE TECHNOLOGIES, INC.
Date Cleared
1997-02-20
(238 days)
Product Code
MNS
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
HEALTHDYNE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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