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510(k) Data Aggregation
K Number
K030611Device Name
MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM
Manufacturer
Date Cleared
2003-03-24
(26 days)
Product Code
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
NELLCOR PURITAN BENNETT (MELVILLE) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nellcor Puritan Bennett Suzanne is intended for use in collecting and recording physiological data to be used in diagnosing sleep disorders. A pediatric through adult patient population is intended for the Suzanne, which can be used in either home or hospital environments.
Device Description
The Suzanne System is composed of a data recorder that contains the electronics and software necessary to capture the physiological information of each sensor and to store this information in a Flash card or to send it to a computer via a serial communication port. The information that can be recorded by the Suzanne System is : - · EEG signals - · ECG signals - · Pressure signals - · Thoracic movements - Abdominal movements - Breath detection (through bucco-nasal thermistor) . - Flow (through pneumotachometer) - Envelope of ambient sound . - Body position . - Ambient light detection . - Arterial oxyhemoglobin saturation (SpO2) . - Pulse rate . The signals are amplified by different amplifiers contained in elements of the system known as headboxes. When used in a home environment, the data is recorded in the flash card and the clinician uses a setup unit to check that the system works correctly and to set the recording starting time. When used in a clinical environment, the system can be used as described above or data can be recorded to a computer with the use of a PC application software. The system is powered by an internal battery or by a DC power supply.
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