Search Results
Found 1 results
510(k) Data Aggregation
K Number
DEN140024Device Name
cNEP Airway
Manufacturer
Date Cleared
2015-12-23
(492 days)
Product Code
Regulation Number
868.5105Why did this record match?
Applicant Name (Manufacturer) :
Sommetrics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The cNEP Airway Management System is to be used as an aid for maintaining the patency of the upper airway in spontaneously breathing adults undergoing medical procedures less than 2 hours in duration, where the patient is intended to have mild to moderate sedation with non-propofol containing medications.
Device Description
The cNEP Airway Management System is a silicone rubber collar that is attached to the neck by a hydrogel and provides negative suction through a regulated vacuum source (see Figure 1). The vacuum suction allows the device to provide a patent airway during mild to moderate sedation.
Ask a Question
Ask a specific question about this device
Page 1 of 1