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510(k) Data Aggregation
K Number
K192000Device Name
D R Burton OxyPAP
Manufacturer
D R Burton Healthcare, LLC
Date Cleared
2020-02-19
(208 days)
Product Code
BWF
Regulation Number
868.5690Why did this record match?
Applicant Name (Manufacturer) :
D R Burton Healthcare, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The D R Burton® OxyPAP™ device is indicated for the treatment and prevention of atelectasis. It also has the ability to provide supplemental oxygen when used with compressed oxygen. It includes the option of a pressure manometer. The device is for patients (ages 5 years and above) who are capable of following directions for positive airway pressure (PAP) therapy.
Normal use of the D R Burton OxyPAP™ should not be more than 24 hours total combined time.
The environment of use is for hospital and clinical setting.
Device Description
The OxyPAP device is a handheld respiratory therapy device that creates a positive airway pressure. The OxyPAP device is intended to be used by pediatric (ages 5 years and above) and adult patients in the hospital environment, under the supervision of a healthcare professional. The OxyPAP device is a single patient use device.
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