ULTepap Expiratory Positive Airway Pressure (EPAP) Device— 510(k) K191728

Name: FDA 510(k) clearance K191728
Creator: U.S. Food and Drug Administration
Published: 2020-02-21

Substantially Equivalent

Bryggs Medical, LLC

FDA 510(k) clearance K191728 for ULTepap Expiratory Positive Airway Pressure (EPAP) Device, Substantially Equivalent on 2020-02-21. Applicant: Bryggs Medical, LLC. Device class: 2.

Clearance details

Applicant: Bryggs Medical, LLC
Product code: Code OHP
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2019-06-27
Decision date: 2020-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Avon, OH, US

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