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510(k) Data Aggregation
K Number
K100995Device Name
SHIKANI SPEAKING VALVE
Manufacturer
SHIKANI MEDICAL, LLC
Date Cleared
2010-06-25
(77 days)
Product Code
JOH
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
SHIKANI MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To allow airflow over the vocal cords for speaking function. To be used with a standard 15 mm connection on tracheostomy tubes.
Device Description
The Shikani speaking valve consists of a plastic housing with a captured ball that acts as a check valve. Once attached to the tracheostomy tube connector the speaking valve allows the patient to inhale through the tracheostomy tube and exhale across the vocal cords which facilitates speech or phonation.
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