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510(k) Data Aggregation
K Number
K122932Device Name
SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
Manufacturer
FOGLESS INTERNATIONAL AB
Date Cleared
2013-12-23
(455 days)
Product Code
JOH
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
FOGLESS INTERNATIONAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
One way Speaking Valve for spontaneous breathing tracheostomy patients. The device connects directly to an ISO 15mm tracheostomy tube. The valve opens upon inhalation and then closes immediation, forcing the expired gasses through the larynx and mouth to produce speech.
Device Description
One way Speaking Valve
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