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510(k) Data Aggregation
K Number
K112822Device Name
SLEEPSTRIP II
Manufacturer
S.L.P LTD.
Date Cleared
2011-12-27
(90 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
S.L.P LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SleepStrip II is intended to measure apnea/hyponea events during sleep for the purpose of prescreening patients for sleep apnea syndrome. The device is intended to be used by adult patients as prescribed by a physician in either home, hospital or facility use settings.
Device Description
The SleepStrip II is formed like a soft plastic "strip" or patch which is adhesively applied on the face under the nose for one night sleep. The SleepStrip II device comprises the following four main components: 1. Flexible body. 2. Sensor and signal acquisition and analysis hardware and firmware. 3. Battery as a power source. 4. A result display element. The SleepStrip II is designed to show a Sleep Apnea Syndrome (SAS) study results. It includes sensors, hardware and software to facilitate a sleep apnea screening study at the patient's home over one night sleep (under prescription). The SleepStrip II, detects and counts respiratory events (apneas and hypopneas) in real time.
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