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510(k) Data Aggregation
K Number
K022274Device Name
CARECOMPANION PATIENT STATION & NURSE STATION
Manufacturer
NEPTEC DESIGN GROUP, LTD.
Date Cleared
2003-05-29
(318 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
NEPTEC DESIGN GROUP, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CareCompanion Patient Station is intended to be used in conjunction with the CareCompanion Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.
The CareCompanion Patient Station is used upon prescription of an authorized healthcare provider by patients where regular monitoring of vital signs information is indicated. The information is collected from the CareCompanion Patient Station and transmitted over standard telephone lines to a health care professional.
The device does not send any real-time alarms. The device a aid. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
Device Description
The CareCompanion System consists of two components: a transportable Patient Station installed typically in a patient's home; and the Nurse Station, installed in a healthcare provider or professional caregiver's office. The two components communicate with each other through modems over standard telephone lines and transmit real-time video, audio and data between them.
The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.
Using vital signs measurement devices integrated with the Patient Station, the Patient Station is designed to monitor the patient's blood pressure, pulse rate, blood glucose level, weight, blood oxygen saturation level and/or heart, lung and bowel sounds, and transmit this data to the Nurse Station. The data is displayed to the caregiver operating the Nurse Station and also automatically recorded in a patient information database. The heart, lung and bowel sounds may be listened to by the caregiver using a set of headphones supplied with the system.
The Nurse Station consists of two sub-components, the Nurse Station PC, which is a standard PC with supporting peripherals connected to a videophone, which provides the video conferencing functions for the Nurse Station. The Nurse Station PC may also operate as a standalone device for patient data management and record keeping functions.
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K Number
K023286Device Name
CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION
Manufacturer
NEPTEC DESIGN GROUP, LTD.
Date Cleared
2003-05-02
(212 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NEPTEC DESIGN GROUP, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CareCompanion Patient Station is intended to be used in conjunction with the CareCompanion Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.
The CareCompanion Patient Station is used upon prescription of an authorized healthcare provider by patients where regular monitoring of vital signs information is indicated. The vital signs information includes: blood pressure, pulse rate, weight, blood glucose level, blood oxygen saturation level, blood alcohol level, pulmonary function parameters, cardiac function parameters, and heart, lung and bowel sounds. The information is collected from the CareCompanion Patient Station and transmitted over standard telephone lines to a health care professional.
The device does not send any real-time alarms. The device is a diagnostic aid. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
Device Description
The CareCompanion System consists of two components: a transportable Patient Station installed typically in a patient's home; and the Nurse Station, installed in a healthcare provider or professional caregiver's office. The two components communicate with each other through modems over standard telephone lines and transmit real-time video, audio and data between them.
The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.
Using vital signs measurement devices integrated with the Patient Station, the Patient Station is designed to monitor the patient's blood pressure, pulse rate, blood glucose level, blood oxygen saturation level, blood alcohol level, pulmonary function parameters, cardiac function parameters, weight, and/or heart, lung and bowel sounds, and transmit this data to the Nurse Station. The data is displayed to the caregiver operating the Nurse Station and also automatically recorded in a patient information database. The heart, lung and bowel sounds may be listened to by the caregiver using a set of headphones supplied with the system.
The Nurse Station consists of two sub-components, the Nurse Station PC, which is a standard PC with supporting peripherals connected to a videophone, which provides the video conferencing functions for the Nurse Station. The Nurse Station PC may also operate as a standalone device for patient data management and record keeping functions.
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K Number
K020584Device Name
N2000 BASE STATION; N2001 NURSE STATION
Manufacturer
NEPTEC DESIGN GROUP, LTD.
Date Cleared
2002-05-22
(90 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NEPTEC DESIGN GROUP, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CareCompanion Patient Station is intended to be used in conjunction with the CareCompanion Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.
The CareCompanion Patient Station is used upon prescription of an authorized healthcare provider by patients where regular monitoring of vital signs information is indicated. The information is collected from the CareCompanion Patient Station and transmitted over standard telephone lines to a health care professional.
The device does not send any real-time alarms. The device a diagnostic aid. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
Device Description
The CareCompanion System consists of two components: a transportable Patient Station installed typically in a patient's home; and the Nurse Station, installed in a healthcare provider or professional caregiver's office. The two components communicate with each other through modems over standard telephone lines and transmit real-time video, audio and data between them.
The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.
With existing legally marketed vital signs measurement devices integrated with the Patient Station, the Patient Station is designed to monitor the patient's blood pressure, pulse rate, blood glucose level, weight and/or heart, lung and bowel sounds, and transmit this data to the Nurse Station. The data is displayed to the caregiver operating the Nurse Station and also automatically recorded in a patient information database. The heart, lunq and bowel sounds may be listened to by the caregiver using a set of headphones supplied with the system.
Vital signs measurement devices integrated in the CareCompanion are FDA approved devices and are used for the same purposes for which they received 510(k) approval. The Patient Station may be configured for use with one to four devices.
The Nurse Station consists of two sub-components, the Nurse Station PC, which is a standard PC with supporting peripherals connected to a videophone, which provides the video conferencing functions for the Nurse Station. The Nurse Station PC may also operate as a standalone device for patient data management and record keeping functions.
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K Number
K012801Device Name
N2000 BASE STATION, N2001 NURSE STATION
Manufacturer
NEPTEC DESIGN GROUP, LTD.
Date Cleared
2001-11-14
(85 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NEPTEC DESIGN GROUP, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The N2000 Base Station is intended to be used in conjunction with the N2001 Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.
The N2000 Base Station is intended to be used upon prescription of an authorized healthcare provider, by patients where regular monitoring of vital signs information is indicated.
The N2000 Base Station is intended to be used as a means to collect and transmit patient vital signs information over standard telephone lines between the patient, typically at home, and a health care professional at the health care provider's site. The information includes: blood pressure, pulse rate, blood oxygen saturation, blood glucose level, temperature, weight, and heart, lung and bowel sounds. The information is collected upon request of the healthcare provider.
The device is not indicated for diagnostic purposes. The device does not send any real-time alarms. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
Device Description
The HomeCare Information Network System (HINS) consists of two components: the N2000 Base Station installed typically in a patient's home; and the N2001 Nurse Station located in the provider or professional caregiver's office. The two components communicate with each other through modems over standard telephone lines and transmit real-time video, audio and data between them.
The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.
With existing legally marketed vital signs measurement devices integrated with the N2000 Base Station, the N2000 Base Station is designed to monitor the patient's blood pressure, pulse rate, blood oxygen saturation, blood glucose level, temperature, weight and/or heart, lung and bowel sounds, and transmit this data to the N2001 Nurse Station. The real-time data is displayed to the caregiver operating the N2001 Nurse Station and also automatically recorded in a patient information database. The heart, lung and bowel sounds are recorded from the electronic stethoscope supplied with the system.
Vital signs measurement devices integrated in the HINS are FDA approved devices and have received 510(k) approval. The N2000 may be configured for use with one to five devices.
The N2001 Nurse Station consists of two sub-components, the N2001 Nurse Station PC, which is a standard PC with supporting peripherals, and the N2001 Nurse Station Data Client, which provides the video and audio communications and monitoring functions for the Nurse Station. The N2001 Nurse Station PC can operate as a standalone device for patient data management and record keeping functions.
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