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510(k) Data Aggregation
K Number
K133806Device Name
M1 CAPNOGRAPHY MASK
Manufacturer
MONITOR MASK, INC.
Date Cleared
2013-12-31
(15 days)
Product Code
CCK, BYG
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
MONITOR MASK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The M1 Capnography Mask is a single-use device intended for delivering supplemental oxygen and monitoring exhaled carbon dioxide in non-intubated spontaneously breathing patients. Standard oxygen tubing and two female luer ports for gas sample line attachment are included.
Device Description
The M1 Capnography Mask is connected to a gas source for delivering low flow oxygen through flexible tubing to the patient, and at the same time provides a means to attach a capnograph for monitoring exhaled carbon dioxide during nose and mouth breathing. The capnograph gas sample tube attaches to a standard female Luer connector on either the left or right side of the M1 Capnography Mask. The M1 Capnography Mask will initially be made available in only one size, adult large (Model #001).
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