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510(k) Data Aggregation
K Number
K172365Device Name
Panoramic Oxygen Mask (POM)
Manufacturer
Pom Medical, LLC
Date Cleared
2018-04-19
(258 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
Pom Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Panoramic Oxygen Mask (POM) is a single patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes. It is for non-intubated, spontaneously breathing patients greater than 30 kg.
Device Description
The Panoramic Oxygen Mask (POM) is a multi-port mask that serves several functions:
- A standard oxygen mask for when a patient requires supplemental oxygen
- Sampling of exhaled gases for monitoring, typically end-tidal CO2
- Additional ports (membranes) to allow for most types of scopes, probes, and tubes to be inserted while still delivering supplemental O2 and sampling exhaled gases.
The design of the POM's oral or nasal membranes allow access of a scope and are soft and pliable to help maintain the oxygen concentration to the patient while having scopes, etc. inserted through these oral or nasal membranes.
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