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510(k) Data Aggregation
K Number
K120920Device Name
HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA
Manufacturer
HSINER COMPANY
Date Cleared
2012-07-16
(111 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
HSINER COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hsiner Pediatric CPAP Silicone Nasal Mask is intended to be use with patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician.
The Hsiner Nasal Pillow Mask is intended to be use patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician.
Device Description
Hsiner's Pediatric CPAP Silicone Nasal Mask and Hsiner's Nasal Pillow Mask are both product line extensions to their existing line of CPAP interface devices for the application of CPAP/VPAP therapy.
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