Home / 510(k) Clearances / K191728

510(k) K191728

ULTepap Expiratory Positive Airway Pressure (EPAP) Device by Bryggs Medical, LLC — Product Code OHP

K191728 is an FDA 510(k) premarket notification submitted by Bryggs Medical, LLC for the device "ULTepap Expiratory Positive Airway Pressure (EPAP) Device". The FDA issued a decision of Substantially Equivalent on February 21, 2020. The device falls under product code OHP (Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea), a Class II device regulated under 21 CFR 872.5570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2020
Date Received
June 27, 2019
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.

Other clearances for product code OHP

  • K180619 — Bongo (August 16, 2018)
  • K102404 — PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEE (December 2, 2010)
  • K090398 — PROVENT PROFESSIONAL SLEEP APNEA THERAPY (April 3, 2009)
  • K071560 — PROVENT NASAL DILATOR, MODEL BR2 (February 8, 2008)

FDA data resources