ClearanceBrief
510(k) K110713 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure

WATERPAP VALVE

ApplicantAirways Development, LLC, Cedar Knolls NJ, US
DecisionSubstantially Equivalent, Sep 12, 2011
ReceivedMar 15, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K110713

DateFirm and productCodeLinked 510(k)
Dec 24, 2015Airways Development LLC
Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
Terminated
BYENone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.