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510(k) Data Aggregation
K Number
K990321Device Name
ALPHAMED GEMINI SENSOR, SNORING SENSOR
Manufacturer
ALPHAMED, INC.
Date Cleared
1999-06-01
(120 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
ALPHAMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable AlphaMed Inc. Breathing/Snoring Sensors and Snoring Sensor are used with existing recording devices in support of diagnostic recording of nasal and oral airflow and recording of breath sounds. The sensors are used with patients who require a sleep study recording. The sensors are contraindicated for support of apnea monitoring.
Device Description
The Breathing/Snoring Sensors and Snoring Sensors are disposable, single patient use devices. The Breathing/Snoring Sensors combine breathing and snoring sound sensing capabilities in one sensor. The sensors use a self-generating signal technology. The sensors contain no electronics or software and require no special interface electronics. The sensors attach to the patient with medical grade tape. The Breathing/Snoring Sensors are applied under the nostrils and above the lip. The Breath Sounds sensors are applied to the throat of the patient. The sensors connect to existing recording equipment by means of an AlphaMed Adapter Cable. The existing recording equipment amplifies the signal the sensors generate in response to a temperature change and/or a vibration due to breath sounds. The existing recording device provides patient electrical isolation for the applied sensors. The sensors consist of a temperature and vibration sensitive material covered with conductive ink to collect the electrical charge generated by the temperature and vibration sensitive material. The conductive ink surface has electrodes lead wires attached. The lead wires comply with 21 CFR Part 898 Performance Standards for Electrode Lead Wires and Patient Cables. The lead wires interface to existing sleep recording devices by a supplied Adapter Cable. Different Adapter Cables are available to support interface to various sleep recording instruments.
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