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510(k) Data Aggregation
K Number
K122285Device Name
TABLET COMMANDER
Manufacturer
CARDIOCOM LLC
Date Cleared
2012-08-14
(15 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
CARDIOCOM LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tablet Commander device is for use by patients to collect and transmit general health information, physiological measurements and other data between themselves and a caregiver.
The Tablet Commander makes no diagnosis. Clinical judgment and experience are required to check and interpret the information transmitted. The Tablet Commander is not intended as a substitute for medical care.
Device Description
The Tablet Commander is a software application. Once installed on a commercially-available device, the Tablet Commander software uses standard communication protocols to exchange information with other medical devices (peripherals). Data collected from the medical devices is transmitted back to a database for review by a caregiver. The Tablet Commander software has a user interface which allows the patient and caregiver to communicate using methods which include questions and answers.
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K Number
K091821Device Name
COMMANDER 111, MODEL CD300-CD399
Manufacturer
CARDIOCOM LLC
Date Cleared
2009-08-25
(68 days)
Product Code
DXN, DOA, DQA
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
CARDIOCOM LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Commander III is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.
Device Description
The Commander III is an FDA cleared device (K053303, K053304). It is similar to a simple personal computer with a modem that stores and transmits data to remote locations. The Commander III is cleared for use with a pulse oximeter, a weight scale, a glucose meter, a peak flow meter and a blood pressure cuff. This premarket submission seeks to add an additional pulse oximeter, the PO100, for use with the Commander III. The PO100 is a reusable pulse oximeter that connects to the Cardiocom Commander III via a cable in the same manner as the currently cleared pulse oximeter.
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K Number
K053303Device Name
CARDIOCOM COMMANDER III
Manufacturer
CARDIOCOM LLC
Date Cleared
2005-12-30
(32 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
CARDIOCOM LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Commander III device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.
Device Description
Commander III is similar to a simple personal computer with a modem that stores and transmits data. Commender III connects to a user's telephone line at home. It has a display that asks health related questions to which the user can respond 'Yes', 'No', or select from a list. It contains an integrated blood pressure meter. It also has inputs for devices such as weight scales, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices has not been modified; they are used as supplied from the manufacturer.
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K Number
K053304Device Name
COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM
Manufacturer
CARDIOCOM LLC
Date Cleared
2005-12-30
(32 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
CARDIOCOM LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Commander III device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.
Contraindications, Precautions and Warnings: The Commander III device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check and interpret the information transmitted. The Commander III is not intended as a substitute for medical care.
Device Description
Commander III is similar to a simple personal computer with a modem that stores and transmits data. Commander III connects to a user's telephone line at home. It has a display that asks health related questions to which the user can respond 'Yes', 'No', or select from a list. It also has inputs for devices such as weight scales, blood pressure meters, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices has not been modified; they are used as supplied from the manufacturer.
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