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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 a medical device manufactured by Bryggs Medical, LLC. It received FDA 510(k) clearance on 2020-02-21 under approval 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. It is manufactured by Bryggs Medical, LLC. The 510(k) number is K191728.

When was ULTepap Expiratory Positive Airway Pressure (EPAP) Device approved by the FDA?

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

What company makes ULTepap Expiratory Positive Airway Pressure (EPAP) Device?

ULTepap Expiratory Positive Airway Pressure (EPAP) Device is manufactured by Bryggs Medical, LLC.

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

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

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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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