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510(k) Data Aggregation
K Number
K220533Device Name
Endoscopy Oxygen Mask
Manufacturer
Engineered Medical Systems Inc.
Date Cleared
2022-11-16
(265 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
Engineered Medical Systems Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endoscopy Oxygen Mask 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 Endoscopy Oxygen Mask 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.
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