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FDA 510(k)

ULTepap Expiratory Positive Airway Pressure (EPAP) Device

K-Number: K191728 · 2020-02-21

ApplicantBryggs Medical, LLC
Decision Date2020-02-21
Product CodeOHP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTepap Expiratory Positive Airway Pressure (EPAP) Device is the device name listed in this FDA 510(k) record. The listed applicant is Bryggs Medical, LLC. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K191728. The device is classified under product code OHP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTepap Expiratory Positive Airway Pressure (EPAP) Device?

ULTepap Expiratory Positive Airway Pressure (EPAP) Device is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Bryggs Medical, LLC. The 510(k) number is K191728.

When did ULTepap Expiratory Positive Airway Pressure (EPAP) Device receive FDA 510(k) clearance?

ULTepap Expiratory Positive Airway Pressure (EPAP) Device received FDA 510(k) clearance on 2020-02-21, under 510(k) number K191728.

Who is the listed applicant for ULTepap Expiratory Positive Airway Pressure (EPAP) Device?

The FDA 510(k) record lists Bryggs Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTepap Expiratory Positive Airway Pressure (EPAP) Device?

The FDA product code for ULTepap Expiratory Positive Airway Pressure (EPAP) Device is OHP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04986293CPAP or BiPAP for Motion Mitigation During RadiotherapyRECRUITINGNCT06996509Noninvasive Support for Acute Respiratory Failure in Guillain-Barré SyndromeRECRUITINGNCT01223274Delivery Room CPAP in Extremely Low Birth Weight InfantsCOMPLETEDNCT02030691Tolerance of nHFPV Versus nCPAP in Neonatal Respiratory DistressCOMPLETEDNCT06413134KPAP Adherence Crossover StudyNOT_YET_RECRUITINGNCT06491017Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Wet Mucus Volume During Invasive VentilationRECRUITING

Related Devices (Code: OHP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180619BongoInnomed Healthscience, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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