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510(k) Data Aggregation
K Number
K991446Device Name
BIOSACA SYSTEM, MODEL 800
Manufacturer
Date Cleared
1999-07-23
(88 days)
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
BIOSYS AB (PUBL)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BIO SA CA equipment is indicated for use in the recording, displaying, monitoring, printing and storage of human bioparameters such as brain, heart and muscle activity, eye movement, breathing and body movements.
The B I 0 5 A C A is designed for stationary, ambulatory and mobile operation and may be used in either the patient's home, the hospital or other environments, enabling patients to be investigated under as realistic conditions as possible.
The B I 0 5 A C A unit is intended for use on an adult population. It is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
Device Description
The BIOSACA is a multi-functional and an ambulatory recording device. It is an ambulatory system for the recording, monitoring, storage and transfer of up to 22 bioparameters such as brain, heart and muscle activity, eye movement, blood pressure, breathing, body movements etc. There are applications for the BIOSACA in neurological, cardiology and sleep disorder diagnoses. Function The BIOSACA is a biological signal recorder able to receive and record up to 22 bioparameters - 16 from two headboxes, AC and/or DC, three from the pulse oximeter and three from the sensor pad,
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K Number
K984580Device Name
BIOSACA SYSTEM
Manufacturer
Date Cleared
1999-03-12
(79 days)
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
BIOSYS AB (PUBL)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BIOSACA equipment is indicated for use in the recording, displaying, printing and storage of biological and non-biological signals for sleep monitoring, neurological disorder and epilepsy investigations as a visual aid to the physician. Biological signals include Electroencephalography (EEG), Electromyography (EMG), Electrooculography (EOG), Ballistocardiography, etc. BIOSACA is designed for both stationary and mobile operation and may be used in either the patient's home or the hospital. Biological signals are encountered which can be recorded directly from the patient. Non-biological signals are recorded using indirect methods such as flow of air (breathing), blood pressure, etc. The equipment is suitable for home use as the patient needs only a minimal amount of instructions for home use. The system has no lights or sounds that could confuse the patient. Signals may be stored for later analysis or may be viewed directly in conjunction with the recording. When monitoring, the operator sees the signals at the same time as they are recorded. The Biosaca unit is intended for use on an adult population and at home or in health care facilities. The unit is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
Device Description
The BIOSACA is a multi-functional and an ambulatory recording device. It is a portable system for the recording, monitoring, storage and transfer of up to 22 bioparameters such as brain, heart and muscle activity, eye movement, blood pressure, breathing, body movements etc. There are applications for the BIOSACA in neurological, cardiology and sleep disorder diagnoses. The BIOSACA is a biological signal recorder able to receive and record up to 22 bioparameters - 16 from two headboxes, AC and/or DC, three from the pulse oximeter and three from the sensor pad.
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