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510(k) Data Aggregation
K Number
K180619Device Name
Bongo
Manufacturer
InnoMed Healthscience, Inc.
Date Cleared
2018-08-16
(160 days)
Product Code
OHP
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
InnoMed Healthscience, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bongo is indicated for use in the treatment of mild to moderate obstructive sleep apnea (OSA) in adults >66 lbs.
Device Description
The Bongo intranasal appliance is a simple device which is placed just inside the nostrils. The device directs expiratory flow through small vent ports which increases intranasal pressure similar to the expiratory portion of the breathing cycle during use of the predicate device. The Bongo consists of valve assemblies coupled with nasal inserts. The Bongo has soft nasal inserts to form a seal within the nasal openings. The nasal inserts are offered in various sizes.
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