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U.S. Department of Health and Human Services

Product Classification
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Device external airway
Regulation Description External negative pressure airway aid.
Definition This device is intended to maintain airway patency using negative pressure during mild to moderate sedation.
Physical State The device is a silicone collar that is attached by adhesive and stays on with negative pressure suction.
Technical Method The device provides negative pressure (suction)to the neck through a tube that attaches to the wall outlet of a central vacuum system. The negative pressure is monitored by a user provided regulator that displays the pressure.
Target Area The target area is the surface of the mandible and neck which overlay the upper airway tract.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodePMB
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5105
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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