Bongo

Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

InnoMed Healthscience, Inc.

The following data is part of a premarket notification filed by Innomed Healthscience, Inc. with the FDA for Bongo.

Pre-market Notification Details

• Device ID: K180619
• 510k Number: K180619
• Device Name: Bongo
• Classification: Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
• Applicant: InnoMed Healthscience, Inc. 1701 W. Hillsboro Blvd., Suite 303 Deerfield Beach, FL 33442
• Contact: Javier Collazo
• Correspondent: Paul Dryden; InnoMed Healthscience, Inc. C/o ProMedic, LLC 131 Bay Point Dr. NE Saint Petersburg, FL 33704
• Product Code: OHP
• CFR Regulation Number: 872.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-03-09
• Decision Date: 2018-08-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50833224005156	K180619	000
50833224005118	K180619	000
50833224005002	K180619	000
50833224005026	K180619	000
50833224005033	K180619	000
50833224005040	K180619	000
50833224005057	K180619	000
50833224005125	K180619	000
50833224005132	K180619	000
50833224005149	K180619	000
50833224005019	K180619	000