ClearanceBrief
510(k) K251165 ยท SGR Noninvasive Positive Airway Pressure System, Facility Use

Saans (F4-01-00-000-000)

ApplicantInnaccel Technologies Private Limited, Bengaluru, IN
DecisionSubstantially Equivalent, Jan 6, 2026
ReceivedApr 15, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251165

No recall in the FDA data names this 510(k).

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