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Xhale, Inc.
Xhale, Inc.
Medical device manufacturer in Gainesville, FL.
3
510(k) clearances
0
PMA approvals
0
recalls
Device types
DQA Oximeter
3
510(k) clearances
510(k)
Device
Decision
K171423
Nasal Alar SpO2 Sensor
DQA · Traditional
07/27/2017
SE
K143216
Assurance Alar / Nasal SpO2 Sensor
DQA · Traditional
03/17/2015
SE
K122996
Assurance Alar Sensor Model 10078; Ab-N Adapter Cable Model 10085
DQA · Traditional
04/10/2013
SE