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510(k) K180619

Bongo by Innomed Healthscience, Inc. — Product Code OHP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2018
Date Received
March 9, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.

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  • K090398 — PROVENT PROFESSIONAL SLEEP APNEA THERAPY (April 3, 2009)
  • K071560 — PROVENT NASAL DILATOR, MODEL BR2 (February 8, 2008)